152 Regulatory Affairs Specialist jobs in Canada
Senior Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
**JOB TITLE:**
**Sr Regulatory Affairs Specialist (CMC)**
**KEY RESPONSIBILITIES:**
Plan, manage, and coordinate the preparation, compilation, filing, and approval of high-quality regulatory submissions (NDS, SNDS, ANDS, SANDS, NC, DINA, PDC, etc.) for presentation to Health Canada in eCTD format and as per Health Canadas Guidelines to obtain marketing authorization for new or marketed drug products.
Preparation and review of responses to Health Canada letters (e.g. SDN, NON, NOD, Clarifaxes) in a timely manner; assist in negotiations with Health Canada to ensure prompt regulatory approvals of dossiers under review and in preparation.
Help to manage all regulatory CMC aspects of Bausch Health Canada Inc., Salix and Orapharma products in Canada throughout their lifecycle:
Evaluation of change controls, determination of necessary requirements, preparation and compilation of L3 submissions to maintain the conformity and life cycle of currently marketed products; update of CPIDs and associated regulatory dossiers maintenance.
Projects: critical assessment of data and documents to identify gaps compared to regulatory requirements; identify the required documentation and content of CMC sections in support of registrations in Canada.
Formulate CMC regulatory strategy for marketed products in collaboration with RA Product Leads.
Maintain and ensure regulatory product compliance. Interact, communicate and negotiate with internal and external stakeholders like Health Canada and CMOs.
Maintain current awareness of all regulatory guidelines (Health Canada, ICH, etc.).
Mentor other members of the team on technical aspects.
Support the Sr. Manager RA-CMC, and the GRA-CMC team (US/EU/Latam) as necessary.
**QUALIFICATIONS:**
University Degree, B.Sc. or higher (Masters degree or a PhD)in Health Sciences. A DESS in Drug Development and/or a RAC certification is an asset. Relevant Quality Assurance (analytical)/Compliance experience is also an asset.
Minimum of 6 years of relevant CMC experience in Canadian Pharmaceutical Regulatory Affairs, with experience/expertise in managing drug products and lifecycle from a CMC perspective. Experience with Biologics is also an asset.
Excellent working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products.
Excellent organizational and communication skills (oral and written).
Bilingual (English and French).
Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines.
Entrepreneurship and focus on customer needs; good business acumen and sense of urgency; agility & flexibility; team player and respect of others.
Computer Literacy
Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat, Veeva, Docubridge, Trackwise.
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
Senior Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
**JOB TITLE:**
**Sr Regulatory Affairs Specialist (CMC)**
**KEY RESPONSIBILITIES:**
Plan, manage, and coordinate the preparation, compilation, filing, and approval of high-quality regulatory submissions (NDS, SNDS, ANDS, SANDS, NC, DINA, PDC, etc.) for presentation to Health Canada in eCTD format and as per Health Canadas Guidelines to obtain marketing authorization for new or marketed drug products.
Preparation and review of responses to Health Canada letters (e.g. SDN, NON, NOD, Clarifaxes) in a timely manner; assist in negotiations with Health Canada to ensure prompt regulatory approvals of dossiers under review and in preparation.
Help to manage all regulatory CMC aspects of Bausch Health Canada Inc., Salix and Orapharma products in Canada throughout their lifecycle:
Evaluation of change controls, determination of necessary requirements, preparation and compilation of L3 submissions to maintain the conformity and life cycle of currently marketed products; update of CPIDs and associated regulatory dossiers maintenance.
Projects: critical assessment of data and documents to identify gaps compared to regulatory requirements; identify the required documentation and content of CMC sections in support of registrations in Canada.
Formulate CMC regulatory strategy for marketed products in collaboration with RA Product Leads.
Maintain and ensure regulatory product compliance. Interact, communicate and negotiate with internal and external stakeholders like Health Canada and CMOs.
Maintain current awareness of all regulatory guidelines (Health Canada, ICH, etc.).
Mentor other members of the team on technical aspects.
Support the Sr. Manager RA-CMC, and the GRA-CMC team (US/EU/Latam) as necessary.
**QUALIFICATIONS:**
University Degree, B.Sc. or higher (Masters degree or a PhD)in Health Sciences. A DESS in Drug Development and/or a RAC certification is an asset. Relevant Quality Assurance (analytical)/Compliance experience is also an asset.
Minimum of 6 years of relevant CMC experience in Canadian Pharmaceutical Regulatory Affairs, with experience/expertise in managing drug products and lifecycle from a CMC perspective. Experience with Biologics is also an asset.
Excellent working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products.
Excellent organizational and communication skills (oral and written).
Bilingual (English and French).
Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines.
Entrepreneurship and focus on customer needs; good business acumen and sense of urgency; agility & flexibility; team player and respect of others.
Computer Literacy
Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat, Veeva, Docubridge, Trackwise.
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
Senior Regulatory Affairs Specialist
Posted 6 days ago
Job Viewed
Job Description
**Job details**
Kelly FSP is hiring for a Senior Regulatory Affairs Specialist with our Medical Device Client in Markham, ON.
This is a hybrid position (3 days a week in office)
As a member of our Regulatory team, you will proactively drive launch of new products in Canada through Regulatory expertise and support marketing and product development initiatives by providing strategic regulatory guidance.
As a member of our Regulatory team, you will primarily drive regulatory lifecycle management in Canada, while also supporting new product launches through strategic regulatory guidance
Provide accurate, relevant, and timely information internally and externally, to maintain product regulatory compliance, and to support approval of regulatory submissions in Canada
**Responsibilities Include:**
+ Develop and implement regulatory strategies for obtaining approval of medical devices in Canada, leveraging regulatory intelligence, product assessments, and competitive insights
+ Drive clarity on risks and methods to overcome them to have market centric products in the shortest possible time.
**Regulatory Submissions**
+ Lead the preparation and submission of regulatory dossiers, applications, change notifications, and other product registration activities specific to Health Canada requirements.
+ Prepare robust regulatory applications with right claims to achieve high yield with strategy to accelerate product launch success.
**Regulatory Approval Maintenance**
+ Maintain ongoing surveillance, analysis, and dissemination of all relevant international medical device regulations to ensure regulatory compliance is maintained and internal parties are appropriately informed.
+ Maintain current body of knowledge on regulations and standards that may impact regulatory approvals for products currently being marketed
+ Evaluate impact of changes on regulatory compliance.
**Relationship Management**
+ Interface with regulatory agencies as the need arises and build strong relationships Provide the voice of international regulatory affairs on project planning and cross-functional project teams and drive clarity for market access in the shortest time period with claims strategy.
+ Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
+ Support regulatory, customer and internal audits.
**Compliance**
+ Comply with Company policies, operating procedures, and processes
+ Health and Safety
+ Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
**Qualifications:**
+ Bachelor's Degree in health or biological sciences, or a related field
+ Certificate in Regulatory Affairs or equivalent work experience
+ 5-7 years of regulatory experience in a medical device environment within Health Canada
+ Must have familiarity with current Canadian regulations
+ Developed strategies and documentation to support submissions and approval of medical device applications globally, specifically within Canada
+ Knowledge and understanding of regulations governing medical devices in Canada, USA and Europe is an asset
+ Excellent oral and written communication skills, including technical writing.
+ Computer literate with: Advanced experience in a Windows environment. Advanced experience in MS Word. Advanced experience in MS Excel
+ Experience using database software to manage data and records is an asset.
+ Strong organizational and general administrative skills
+ Demonstrated attention to detail.
+ Strong interpersonal skills with ability to communicate effectively with internal personnel and external parties
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing a workplace environment that is inclusive and respects the dignity of those in our workforce. Consistent with that commitment, Kelly will ensure that persons who are otherwise able to work are not unfairly excluded from doing so based upon any grounds protected by applicable human rights legislation, and will make all reasonable efforts to accommodate the needs of applicants and employees in all employment processes including but not limited to, hiring, advancement, discharge, compensation, or training.
Specialist SARA Regulatory Affairs
Posted 21 days ago
Job Viewed
Job Description
**Are You Ready to Make It Happen at Mondelēz International?**
**Join our Mission to Lead the Future of Snacking. Make It With Pride.**
You execute the regulatory affairs strategy for your respective categories and geographical area using your technical and regulatory expertise. You ensure the regulatory and policy compliance of our portfolio and ensure policies, regulatory programs and requirements are met.
**How you will contribute**
You will implement the regulatory affairs strategy and work with cross-functional teams to anticipate regulatory business risks and opportunities. In addition, you will provide regulatory affairs expertise for technical regulatory developments and help with responses to challenges and crisis management. In this role, you will ensure that ingredients, product composition, claims and labelling is in compliance with regulations and company policies, provide guidance to stakeholders on regulatory affairs, propose and implement business solutions in response to regulatory changes, and maintain and develop a strong knowledge of regulatory, scientific and nutrition risks and opportunities in your corresponding market.
**What you will bring**
A desire to drive your future and purpose, accelerate your career and the following experience and knowledge:
+ Regulatory affairs (industry, governmental, association background).
+ Understanding of the regulatory framework in your geographical area
+ Building collaborative relationships
+ Conducting technical assessments and supporting issues management
+ Thinking creatively
+ Communicating effectively
+ Project management
+ SARA core knowledge topics (e.g. flavors, additives, GMO, organic, dietary or religious suitability, etc.)
**What you will bring**
A desire to drive your future and purpose, accelerate your career and the following experience and knowledge:
Regulatory affairs (industry, governmental, and association background).
Understanding of the regulatory framework in your geographical area
Building collaborative relationships
Conducting technical assessments and supporting issues management
Thinking creatively
Communicating effectively
Project management
SARA core knowledge topics (e.g. flavors, additives, GMO, organic, dietary or religious suitability, etc.)
**More about this role**
The position is with the North American Regulatory Ingredients and Global Import Export team.
The scope of work includes reviewing and coordinating the revision of ingredient compliance against US FDA and Health Canada requirements and ensuring regulatory information excellence in the ingredient specifications.
Ability to interpret complex ingredient regulations and laws for food and recommend compliance strategies that balance risk with business impact and cost.
Experience with PLM is a requirement. Experience with MS Teams and other MS Apps is an asset.
The role will also be responsible for GIE RA brand/category continuity, leading the strategy and decision-making, adapting to the business needs.
Strong organization and leadership, acting like an owner, proactively collaborating with business partners and regulatory colleagues to develop strategies and recommended action plans to advance complex business initiatives.
Work autonomously and through others to facilitate deployment/ delivery of all regulatory project elements (compliance, claims, labeling) as required.
Interface and collaborate across different functions of the organization to ensure project outcomes are achieved with high-quality results and gain their alignment and support.
This candidate will be expected to be involved in and make contributions to the North American SARA community/pillars/programs/tools.
**Education / Certifications:**
Bachelor's degree in nutrition, Food Science, or related scientific discipline
**Job-specific requirements**
Desired experience with US FDA and Health Canada food regulations, specifications, and labeling databases.
**Work schedule:**
Regular business hours
**Work schedule: Full time**
No Relocation support available
**Business Unit Summary**
**Mondelēz International is the world's largest chocolate, biscuit and candy maker, and the second largest gum maker. Our North American and U.S. headquarters are in East Hanover, New Jersey, about 25 miles outside of New York City. We have Canadian offices in Toronto and Montreal. We have a strong North American manufacturing presence where we make our well-loved snacks like** **_Oreo_** **cookies,** **_belVita_** **breakfast biscuits,** **_Trident_** **gum and** **_Cadbury_** **chocolates. Our East Hanover location also houses our global research and development center for our consumer-favorite cookie and cracker brands.**
USA:
Mondelēz Global LLC is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, sexual orientation, gender identity, gender expression, genetic information, or any other characteristic protected by law. Applicants who require accommodation to participate in the job application process may contact for assistance.
Canada:
If you are applying to a position in Canada, accommodations for applicants with disabilities or other grounds protected by human rights legislation are available upon request for candidates taking part in all aspects of the employment selection process. For all internal and external applicants who require accommodation in the recruitment and selection process please contact for assistance/support.
**Job Type**
Regular
Scientific Affairs & Regulatory Affairs
Product Quality, Safety and Compliance
At Mondelēz International, our purpose is to empower people to snack right through offering the right snack, for the right moment, made the right way. That means delivering a broader range of delicious, high-quality snacks that nourish life's moments, made with sustainable ingredients and packaging that consumers can feel good about.
We have a rich portfolio of strong brands - both global and local. Including many household names such as Oreo, belVita and LU biscuits; Cadbury Dairy Milk, Milka and Toblerone chocolate; Sour Patch Kids candy and Trident gum. We are proud to hold the number 1 position globally in biscuits, chocolate and candy as well as the No. 2 position in gum
Our 80,000 Makers and Bakers are located in our operations in more than 80 countries and are working to sell our products in over 150 countries around the world. They are energized for growth and critical to us living our purpose and values. We are a diverse community that can make things happen, and happen fast.
Join us and Make It An Opportunity!
Mondelez Global LLC is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, sexual orientation, gender identity, gender expression, genetic information, or any other characteristic protected by law. Applicants who require accommodation to participate in the job application process may contact for assistance.
Spécialiste, Affaires réglementaires / Specialist, Regulatory Affairs
Posted today
Job Viewed
Job Description
ENGLISH version below
Spécialiste, Affaires réglementaires
Pourquoi Jubilant Radiopharma ?
Chez Jubilant Radiopharma, nous sommes déterminés à avoir un impact significatif sur la vie des patients en fournissant des produits radio pharmaceutiques de haute qualité. En tant que leader de l'industrie, nous offrons des opportunités passionnantes de croissance et de développement professionnels, ainsi qu'un environnement de travail collaboratif où vos contributions sont valorisées et reconnues.
Faites avancer la science. Assurez la conformité. Influencez l’avenir.
Vous êtes passionné(e) par la rigueur scientifique et la réglementation pharmaceutique? Vous souhaitez jouer un rôle clé dans le développement et la mise en marché de médicaments novateurs et génériques? Rejoignez une équipe dynamique où votre expertise aura un impact direct sur la santé publique et la réussite de l’entreprise.
Vos responsabilités :
- Agir comme expert(e) réglementaire auprès des équipes R&D, Fabrication, Assurance qualité, Marketing et Affaires cliniques.
- Préparer et soumettre la documentation pharmaceutique et technique pour les essais cliniques, la commercialisation et les mises à jour de produits.
- Analyser les exigences réglementaires et évaluer la conformité des données et procédures.
- Rédiger les résumés techniques et pharmaceutiques, les étiquettes et les soumissions électroniques pour Santé Canada, la FDA et d'autres autorités internationales.
- Assurer la conformité continue en gérant les modifications post-approbation et les enregistrements d’établissement.
- Recommander des ajustements aux protocoles cliniques, à l’étiquetage ou à la fabrication pour maintenir la conformité.
- Participer à des projets transversaux et contribuer à l’amélioration continue des processus réglementaires.
Profil recherché :
- Maîtrise en chimie, biochimie, biologie ou domaine connexe (ou baccalauréat avec expérience pertinente).
- 1 à 3 ans d’expérience en affaires réglementaires.
- Expérience dans l’industrie pharmaceutique un atout.
- Bilingue en français et en anglais (doit interagir avec les agences réglementaires situées hors du Québec)
- Sens aigu du détail, autonomie, fiabilité et bon jugement.
- Capacité à gérer plusieurs projets simultanément.
- Solides compétences en organisation, planification et communication.
Specialist, Regulatory Affairs
Why Jubilant Radiopharma?
At Jubilant Radiopharma, we are dedicated to making a meaningful impact in the lives of patients by delivering high-quality radiopharmaceuticals. As a leader in the industry, we offer exciting opportunities for professional growth and development, along with a collaborative work environment where your contributions are valued and recognized.
Advance science. Ensure compliance. Shape the future.
Are you passionate about scientific rigor and pharmaceutical regulations? Do you want to play a key role in the development and commercialization of both innovative and generic drugs? Join a dynamic team where your expertise directly impacts public health and company success.
Your Responsibilities:
- Act as a regulatory expert for cross-functional teams including R&D, Manufacturing, Quality Assurance, Marketing, and Clinical Affairs.
- Prepare and submit pharmaceutical and technical documentation for clinical trials, product marketing, and updates to existing products.
- Analyze regulatory requirements and assess the compliance of data and procedures.
- Draft technical summaries, labeling, and electronic submissions for Health Canada, FDA, and other international authorities.
- Ensure ongoing compliance by managing post-approval changes and establishment registrations.
- Recommend adjustments to clinical protocols, labeling, or manufacturing to maintain regulatory compliance.
- Contribute to cross-functional projects and continuous improvement of regulatory processes.
What We’re Looking For:
- Master’s degree in Chemistry, Biochemistry, Biology or related field (or Bachelor’s with relevant industry experience).
- 1 to 3 years of Regulatory Affairs experience.
- Experience in pharmaceutical industry is an asset.
- Bilingual in French and English (must interact with regulatory agencies based outside Quebec)
- Detail-oriented, autonomous, reliable, and sound judgment.
- Ability to manage multiple projects simultaneously.
- Strong organizational, planning, and communication skills.
Spécialiste, Affaires réglementaires / Specialist, Regulatory Affairs
Posted 5 days ago
Job Viewed
Job Description
ENGLISH version below
Spécialiste, Affaires réglementaires
Pourquoi Jubilant Radiopharma ?
Chez Jubilant Radiopharma, nous sommes déterminés à avoir un impact significatif sur la vie des patients en fournissant des produits radio pharmaceutiques de haute qualité. En tant que leader de l'industrie, nous offrons des opportunités passionnantes de croissance et de développement professionnels, ainsi qu'un environnement de travail collaboratif où vos contributions sont valorisées et reconnues.
Faites avancer la science. Assurez la conformité. Influencez l’avenir.
Vous êtes passionné(e) par la rigueur scientifique et la réglementation pharmaceutique? Vous souhaitez jouer un rôle clé dans le développement et la mise en marché de médicaments novateurs et génériques? Rejoignez une équipe dynamique où votre expertise aura un impact direct sur la santé publique et la réussite de l’entreprise.
Vos responsabilités :
- Agir comme expert(e) réglementaire auprès des équipes R&D, Fabrication, Assurance qualité, Marketing et Affaires cliniques.
- Préparer et soumettre la documentation pharmaceutique et technique pour les essais cliniques, la commercialisation et les mises à jour de produits.
- Analyser les exigences réglementaires et évaluer la conformité des données et procédures.
- Rédiger les résumés techniques et pharmaceutiques, les étiquettes et les soumissions électroniques pour Santé Canada, la FDA et d'autres autorités internationales.
- Assurer la conformité continue en gérant les modifications post-approbation et les enregistrements d’établissement.
- Recommander des ajustements aux protocoles cliniques, à l’étiquetage ou à la fabrication pour maintenir la conformité.
- Participer à des projets transversaux et contribuer à l’amélioration continue des processus réglementaires.
Profil recherché :
- Maîtrise en chimie, biochimie, biologie ou domaine connexe (ou baccalauréat avec expérience pertinente).
- 1 à 3 ans d’expérience en affaires réglementaires.
- Expérience dans l’industrie pharmaceutique un atout.
- Bilingue en français et en anglais (doit interagir avec les agences réglementaires situées hors du Québec)
- Sens aigu du détail, autonomie, fiabilité et bon jugement.
- Capacité à gérer plusieurs projets simultanément.
- Solides compétences en organisation, planification et communication.
Specialist, Regulatory Affairs
Why Jubilant Radiopharma?
At Jubilant Radiopharma, we are dedicated to making a meaningful impact in the lives of patients by delivering high-quality radiopharmaceuticals. As a leader in the industry, we offer exciting opportunities for professional growth and development, along with a collaborative work environment where your contributions are valued and recognized.
Advance science. Ensure compliance. Shape the future.
Are you passionate about scientific rigor and pharmaceutical regulations? Do you want to play a key role in the development and commercialization of both innovative and generic drugs? Join a dynamic team where your expertise directly impacts public health and company success.
Your Responsibilities:
- Act as a regulatory expert for cross-functional teams including R&D, Manufacturing, Quality Assurance, Marketing, and Clinical Affairs.
- Prepare and submit pharmaceutical and technical documentation for clinical trials, product marketing, and updates to existing products.
- Analyze regulatory requirements and assess the compliance of data and procedures.
- Draft technical summaries, labeling, and electronic submissions for Health Canada, FDA, and other international authorities.
- Ensure ongoing compliance by managing post-approval changes and establishment registrations.
- Recommend adjustments to clinical protocols, labeling, or manufacturing to maintain regulatory compliance.
- Contribute to cross-functional projects and continuous improvement of regulatory processes.
What We’re Looking For:
- Master’s degree in Chemistry, Biochemistry, Biology or related field (or Bachelor’s with relevant industry experience).
- 1 to 3 years of Regulatory Affairs experience.
- Experience in pharmaceutical industry is an asset.
- Bilingual in French and English (must interact with regulatory agencies based outside Quebec)
- Detail-oriented, autonomous, reliable, and sound judgment.
- Ability to manage multiple projects simultaneously.
- Strong organizational, planning, and communication skills.
Spécialiste, Affaires réglementaires / Specialist, Regulatory Affairs
Posted 5 days ago
Job Viewed
Job Description
ENGLISH version below
Spécialiste, Affaires réglementaires
Pourquoi Jubilant Radiopharma ?
Chez Jubilant Radiopharma, nous sommes déterminés à avoir un impact significatif sur la vie des patients en fournissant des produits radio pharmaceutiques de haute qualité. En tant que leader de l'industrie, nous offrons des opportunités passionnantes de croissance et de développement professionnels, ainsi qu'un environnement de travail collaboratif où vos contributions sont valorisées et reconnues.
Faites avancer la science. Assurez la conformité. Influencez l’avenir.
Vous êtes passionné(e) par la rigueur scientifique et la réglementation pharmaceutique? Vous souhaitez jouer un rôle clé dans le développement et la mise en marché de médicaments novateurs et génériques? Rejoignez une équipe dynamique où votre expertise aura un impact direct sur la santé publique et la réussite de l’entreprise.
Vos responsabilités :
- Agir comme expert(e) réglementaire auprès des équipes R&D, Fabrication, Assurance qualité, Marketing et Affaires cliniques.
- Préparer et soumettre la documentation pharmaceutique et technique pour les essais cliniques, la commercialisation et les mises à jour de produits.
- Analyser les exigences réglementaires et évaluer la conformité des données et procédures.
- Rédiger les résumés techniques et pharmaceutiques, les étiquettes et les soumissions électroniques pour Santé Canada, la FDA et d'autres autorités internationales.
- Assurer la conformité continue en gérant les modifications post-approbation et les enregistrements d’établissement.
- Recommander des ajustements aux protocoles cliniques, à l’étiquetage ou à la fabrication pour maintenir la conformité.
- Participer à des projets transversaux et contribuer à l’amélioration continue des processus réglementaires.
Profil recherché :
- Maîtrise en chimie, biochimie, biologie ou domaine connexe (ou baccalauréat avec expérience pertinente).
- 1 à 3 ans d’expérience en affaires réglementaires.
- Expérience dans l’industrie pharmaceutique un atout.
- Bilingue en français et en anglais (doit interagir avec les agences réglementaires situées hors du Québec)
- Sens aigu du détail, autonomie, fiabilité et bon jugement.
- Capacité à gérer plusieurs projets simultanément.
- Solides compétences en organisation, planification et communication.
Specialist, Regulatory Affairs
Why Jubilant Radiopharma?
At Jubilant Radiopharma, we are dedicated to making a meaningful impact in the lives of patients by delivering high-quality radiopharmaceuticals. As a leader in the industry, we offer exciting opportunities for professional growth and development, along with a collaborative work environment where your contributions are valued and recognized.
Advance science. Ensure compliance. Shape the future.
Are you passionate about scientific rigor and pharmaceutical regulations? Do you want to play a key role in the development and commercialization of both innovative and generic drugs? Join a dynamic team where your expertise directly impacts public health and company success.
Your Responsibilities:
- Act as a regulatory expert for cross-functional teams including R&D, Manufacturing, Quality Assurance, Marketing, and Clinical Affairs.
- Prepare and submit pharmaceutical and technical documentation for clinical trials, product marketing, and updates to existing products.
- Analyze regulatory requirements and assess the compliance of data and procedures.
- Draft technical summaries, labeling, and electronic submissions for Health Canada, FDA, and other international authorities.
- Ensure ongoing compliance by managing post-approval changes and establishment registrations.
- Recommend adjustments to clinical protocols, labeling, or manufacturing to maintain regulatory compliance.
- Contribute to cross-functional projects and continuous improvement of regulatory processes.
What We’re Looking For:
- Master’s degree in Chemistry, Biochemistry, Biology or related field (or Bachelor’s with relevant industry experience).
- 1 to 3 years of Regulatory Affairs experience.
- Experience in pharmaceutical industry is an asset.
- Bilingual in French and English (must interact with regulatory agencies based outside Quebec)
- Detail-oriented, autonomous, reliable, and sound judgment.
- Ability to manage multiple projects simultaneously.
- Strong organizational, planning, and communication skills.
Be The First To Know
About the latest Regulatory affairs specialist Jobs in Canada !
Senior Legal Advisor Compliance
Posted 2 days ago
Job Viewed
Job Description
As a Senior Legal Advisor within the Operational Compliance team, you act as a compliance expert supporting the sectors of the Investment Operations Group. This role allows you to have a tangible impact on governance by ensuring regulatory standards are met, implementing industry best practices, and influencing strategic decisions.
Joining our team means contributing to large-scale projects, growing in a stimulating and collaborative environment, and making a real difference in compliance governance.
Your Role Ensure the effective application of compliance policies in supported sectors through projects, targeted reviews, and specific cases.
Act as an expert with government authorities regarding registered plans, and address complex regulatory issues.
Lead process changes related to compliance, anticipating their impact on future operations.
Chair governance committees involving partners and compliance, and represent the organization in industry forums.
Proactively monitor regulatory developments, maintain up-to-date requirements, and communicate compliance obligations to teams.
Provide strategic recommendations during the implementation of new processes to ensure regulatory compliance and operational efficiency.
Support teams during internal and external audits, ensuring consistency and rigor in compliance practices.
Your Team Within the Investment Operations sector, you’ll be part of a team of 15 colleagues and report to the Senior Director, Operational Compliance and QI-QDD Programs. Our team is known for its collaborative and enjoyable atmosphere, while maintaining rigor and agility in a constantly evolving environment. Everyone actively contributes to high-value, practical solutions.
We promote a variety of continuous learning approaches to support your development, including hands-on learning, accessible training content, and collaborative work with colleagues from diverse areas of expertise.
Prerequisites A completed Bachelor’s degree in a related field and at least 6 years of relevant experience, or a completed Master’s degree and at least 4 years of relevant experience
Member in good standing of the Chambre des notaires du Québec or the Barreau du Québec
Strong knowledge of wealth management compliance requirements, including AML/ATF, and relevant experience in compliance
Excellent skills in analysis, influence, and communication
Your benefits In addition to competitive compensation, upon hiring you’ll be eligible for a wide range of flexible benefits to help promote your wellbeing and that of your family. * Health and wellness program, including many options * Flexible group insurance * Generous pension plan * Employee Share Ownership Plan * Employee and Family Assistance Program * Preferential banking services * Opportunities to get involved in community initiatives * Telemedicine service * Virtual sleep clinic These are a few of the benefits available to you. We have an offer that keeps up with trends as well as your needs and those of your family. Our dynamic work environments and cutting-edge collaboration tools foster a positive employee experience. We actively listen to employees’ ideas. Whether through our surveys or programs, regular feedback and ongoing communication is encouraged. We're putting people first We're a bank on a human scale that stands out for its courage, entrepreneurial culture, and passion for people. Our mission is to have a positive impact on peoples' lives. Our core values of partnership, agility, and empowerment inspire us, and inclusivity is central to our commitments. We offer a barrier-free workplace that is accessible to all employees. We want our recruitment process to be fully accessible. If you require accommodation, feel free to let us know during your first conversations with us. We welcome all candidates! What can you bring to our team? Come live your ambitions with us!
Senior Legal Advisor Compliance
Posted 3 days ago
Job Viewed
Job Description
A career as a Senior Legal Advisor in the Personal & Commercial Compliance - Business Conduct team means acting as a regulatory expert to support sound risk management. This role allows you to have a direct impact by contributing to consumer protection, anti-money laundering efforts, and the efficiency of our compliance processes.
Your role Act as a specialist for the Compliance team in interpreting and applying regulatory requirements to the activities of the Personal Financing and Mortgage Financing value chains.
Support business partners in these value chains to ensure their activities comply with applicable laws and regulations (Bank Act, Consumer Protection Framework, PCMLTFA, etc.).
Lead and contribute to projects, mandates, and complex analyses, while proposing practical solutions to regulatory issues.
Continuously monitor regulatory risks and recommend measures to mitigate them and improve operational effectiveness.
Develop, maintain, and enhance a regulatory supervision program, and carry out proactive, ongoing supervision.
Your team Within the Regulatory Compliance sector (2nd line of defense), you are part of a team of 10 dynamic colleagues and report to the Senior Director, Business Conduct Personal & Commercial. Our team stands out for its diverse expertise, collaborative mindset, and commitment to innovation in anticipating regulatory trends. We aim to provide you with maximum flexibility to support your quality of life, through a hybrid work model that combines remote work with in-office presence.
National Bank values continuous development and internal mobility. Our personalized training programs, based on learning through action, allow you to master your role and expand into new areas of expertise.
Prerequisites Member in good standing of the Barreau or the Chambre des notaires du Québec, with at least 8 years of relevant experience.
Significant experience in regulatory compliance or risk management.
Strong knowledge of regulations applicable to the banking industry (Bank Act, Consumer Protection Framework, AML/ATF, etc.).
Familiarity with the activities and operational processes of the Personal Financing and Mortgage Financing sectors.
Influential leadership and autonomy in a context of transformation.
Your benefits In addition to competitive compensation, upon hiring you’ll be eligible for a wide range of flexible benefits to help promote your wellbeing and that of your family. * Health and wellness program, including many options * Flexible group insurance * Generous pension plan * Employee Share Ownership Plan * Employee and Family Assistance Program * Preferential banking services * Opportunities to get involved in community initiatives * Telemedicine service * Virtual sleep clinic These are a few of the benefits available to you. We have an offer that keeps up with trends as well as your needs and those of your family. Our dynamic work environments and cutting-edge collaboration tools foster a positive employee experience. We actively listen to employees’ ideas. Whether through our surveys or programs, regular feedback and ongoing communication is encouraged. We're putting people first We're a bank on a human scale that stands out for its courage, entrepreneurial culture, and passion for people. Our mission is to have a positive impact on peoples' lives. Our core values of partnership, agility, and empowerment inspire us, and inclusivity is central to our commitments. We offer a barrier-free workplace that is accessible to all employees. We want our recruitment process to be fully accessible. If you require accommodation, feel free to let us know during your first conversations with us. We welcome all candidates! What can you bring to our team? Come live your ambitions with us!