141 Pharmaceutical Regulations jobs in Canada
PV Affiliate Drug Safety Officer, Canada
Posted 5 days ago
Job Viewed
Job Description
**What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.**
Making a positive impact on patients' lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
**About Us:**
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
**In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.**
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
**Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.**
**Purpose and Scope:**
Leads Pharmacovigilance (PV) at affiliate level, with line management responsibility as applicable. Acts in alignment with global functional and local Brand Team objectives and priorities as appropriate, with overall responsibility for all products in scope of the affiliate(s).
In close coordination with the RAPV Affiliate Lead, this role is responsible for:
+ Development and execution of the affiliate PV strategy, planning and objectives.
+ Effective operation and oversight of the local PV system and acting as the local PV contact person / local Qualified Person for PV (L-QPPV), as applicable.
+ Responsible for acting as the local Drug Safety Officer (DSO) and manage its related duties.
+ Compliance with applicable policies / procedures, laws / regulations / guidelines and contractual agreements as well as continuous improvement of the affiliate's PV Quality Management System, including effective regulatory intelligence and change management.
+ Representing Astellas towards local Health Authorities and pharmaceutical industry associations on all matters PV, as applicable.
+ Responsible for monitoring and reviewing the Pharmacovigilance activities at affiliate level, whilst overseeing the systematic collection and documentation of Product Safety information and related activities and passing information to all other relevant stakeholders that could include the Health Authority.
+ Responsible for collecting relevant publicly available PV information and use this information to inform relevant people.
**Essential Job Duties**
+ Liaison on a strategic and operational level with the Affiliate RAPV Lead, headquarters, EU-QPPV / L-QPPV and local Business Partners, as applicable - on all matters PV.
+ Anticipates fluctuating workload and ensures adequate resourcing and prioritization.
+ Acts as primary contact for (potential) safety issues at the responsible country / countries and/or affiliate(s).
+ Mentors and manages other affiliate staff with PV responsibilities in a matrix setting, as applicable.
+ Pro-actively identifies and mitigates risks in collaboration with cross-functional teams.
+ Supports maintaining Astellas' reputation through protection of patient safety.
+ Provides strategic and operational support to brand-centric activities (e.g., Early Access Programs and Patient Support Programs).
The responsibilities of a DSO furthermore include, but are not limited to:
+ High-quality PV record management.
+ Develops and maintains local procedures to ensure adherence to applicable PV requirements.
+ Provides adequate PV training as required.
+ Effectively works cross-functionally to ensure compliant and up-to-date PV-related contractual arrangements.
+ Adequately collects and manages product safety information from all applicable sources and ensures that the
+ Global Safety Database (GSD) is used to record source information accurately, timely and completely at
+ affiliate level. Maintains effective oversight of local / regional / global suppliers that manage this activity permanently or temporarily.
+ Ensures that safety information (Adverse Events) received from all sources (e.g literature search, Market Research, Patient Support, Digital Media) by the affiliate are collected, translated and forwarded to designated Regional Global PV Headquarter, in compliance with required timelines (reporting timelines), quality guidelines and standards, as applicable.
+ Overseeing and monitoring compliance of case documentation, as applicable.
+ Distributes and/or submits ICSRs to relevant destinations, as applicable.
+ Periodically reviews local literature, as applicable.
+ Distributes / submits aggregate reports such as Periodic Safety Update Reports (PSURs) to Competent Authorities (CAs) and Suspected Unexpected Serious Adverse Reaction (SUSAR) Line Listings (LLs) to Investigators, as required. Manages local translations and creation of annexes and cover letters where required.
+ Distributes / submits Risk Management Plans, where required with local translations (as required) and cover letter. Creation and maintenance of L-RMPs as applicable.
+ Adequately and timely implements additional Risk Minimization Measures, as applicable.
+ Manages local signal detection- and management-related activities.
+ Manages outsourced partners to ensure PV activities are conducted according to the relevant procedures, as applicable
+ Responsible for the development and maintenance of locally applicable PV Quality documents.
+ Ensures filing, storage and archiving of PV documentation in accordance with PV regulations and with Astellas policies and procedures
+ Request to have access to, and be aware of, the affiliate business continuity plan (for example system failure and other disasters) in relation to PV activities. Responsible for ensuring a local mechanism is in place for 24/7 availability to enable appropriate handling of potential urgent safety issues by the affiliate.
+ Ensures timely and compliant management of locally required post-authorization studies, as applicable.
+ Ensures effective PV business continuity arrangements and PV-related third party life-cycle management.
+ Leads PV system audits, inspections and management of non-conformances and Corrective Actions and Preventive Action (CAPA) plans.
+ Appropriately handles potential safety issues as well as timely communication of information that requires notification to local Health Authorities and timely responses to local Health Authority requests.
+ Ensures up-to-date content for the (L-)PV System Master File (PSMF).
+ Supports management of the affiliate PV budget in a cost-efficient manner.
**Required Qualifications**
+ BS Degree in pharmacy, medical, life sciences, chemistry or similar
+ 5+ years relevant experience in a PV role and/or combined PV/QA/QA; to include direct contact and engagement with national Health Authority.
**Preferred Qualification**
+ Demonstrated knowledge of Canadian PV regulations and guidelines (other jurisdictions is an asset)
+ Relevant external pharmaceutical (professional) training with an advanced professional degree
**Additional Information**
Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.
Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.
_No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted._
Category RAPV Affiliates: Established Markets
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Associate, Regulatory Affairs
Posted 5 days ago
Job Viewed
Job Description
The **Regulatory Affairs Associate** is responsible for supporting new drug product registrations and maintaining current drug product registrations for our Canadian Brand Specialty portfolio. This role plays a pivotal part in ensuring regulatory compliance, timely submissions, and successful approvals from Health Canada.
**Duties and responsibilities**
+ Assist with planning, preparing, coordinating, compiling, reviewing and submitting regulatory dossiers (e.g., NDS, SNDS, NC, Level III Changes) to Health Canada
+ Prepare responses to Health Canada clarification requests in a timely manner throughout the submission lifecycle
+ Maintain current drug product registrations and support post-approval regulatory activities
+ Review product packaging, labeling, and promotional materials for compliance
+ Review change controls and assess impact of regulatory updates and support implementation of necessary changes
+ Track submission milestones and post-approval commitments
+ Support product launch activities from a regulatory perspective
+ Support regulatory strategy development for new product filings and lifecycle management
+ Monitor and interpret changes in Canadian regulatory guidance
+ Maintain accurate and organized regulatory documentation
+ Work closely with departments including Quality, R&D, Marketing, and Supply Chain
+ Other regulatory responsibilities as required by the Director
**Additional responsibility (Only applicable to customer facing roles)**
+ Report any adverse event received from customers for company products to the pharmacovigilance/drug safety department within 1 business day
**Qualifications**
**Knowledge, Skills and Abilities:**
+ Familiarity with Health Canada regulatory guidelines and submission processes (including chemistry and manufacturing, labeling and format requirements)
+ Ability to interpret regulations and create compliant documentation
+ Strong interpersonal, written and verbal communication skills
+ Excellent organizational and time-management abilities to adhere to submission timelines
+ Comfortable working on multiple priorities and deadlines
+ High attention to detail and accuracy
+ Collaborative and adaptable in fast-paced environments
+ Proactive problem-solving mindset with a focus on compliance and quality
+ Proficiency with Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat and document management systems
+ Knowledge of GMP requirements and QA/QC procedures
**Background and Experience:**
+ Bachelors degree in Life Sciences, Pharmacy, Chemistry, or a related field
+ Postgraduate studies or certification in Regulatory Affairs (e.g., RAPS, TOPRA) is an asset
+ 3 or greater years of drug or drug/device regulatory affairs experience within the pharmaceutical or healthcare industry
**Working conditions**
+ Local Canadian office
+ Extensive use of computer
+ Varied work schedule to meet deadlines, as required
**Physical requirements**
+ Hybrid role (in office at least 3 days a week)
**Direct reports**
NA
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Regulatory Affairs Coordinator
Posted 3 days ago
Job Viewed
Job Description
About the Company:
Inspired by the Mediterranean, Moroccanoil comes to life through our iconic turquoise packaging and signature fragrance, for an exotic experience that transports the senses. Our original Moroccanoil Treatment pioneered oil-infused haircare and sparked global interest in argan oil. At the heart of our brand is the stylist community that inspires us to create effective and easy-to-use products.
Today, our mission remains unchanged: to pioneer beauty innovations while making a positive impact. We support animal welfare as a cruelty-free brand with our PETA Beauty without Bunnies certification and partnership with the Humane Society. Ocean conservation and sustainability are central to us, including our collaboration with Oceana. As our journey continues, we strive to make a meaningful difference in our communities and around the world.
Requirements
Key responsibilities involve:
- Performing regulatory reviews on raw materials, formulations and packaging to confirm compliance with all relevant regulations with particular emphasis on US FDA and Health Canada, and ensuring all products offered meet required standards and regulations.
- Working closely with Product Development and Marketing departments to provide regulatory input on projects related to new developments or changes to existing products from the point of view of regulatory framework and compliance.
- Providing support to Marketing team to ensure all product claims are substantiated properly to comply with regulations.
- Ensuring product testing protocols comply with regulatory requirements or defined industry standards.
- Constantly monitoring, analyzing and providing impact assessment on all regulatory changes in different markets and communicates this information with relevant departments including Product Development and Production to ensure company remains complaint with all regulations over time.
Qualifications:
- 1 to 4 years of work experience in similar or relevant field, preferably in the cosmetic industry.
- Knowledge of US FDA cosmetic and OTC products regulations, the Food Drug and Cosmetic Act (FD&C), The Fair Packaging and Labeling Act (FPLA), California Prop 65 and other relevant local, state and federal regulations.
- Knowledge of Health Canada regulations and notification process.
- Ability to understand and analyze safety assessment reports.
- Knowledge of global INCI databases.
- Demonstrates excellent verbal and written communications skills in English; French and/or Hebrew an asset.
- Able to take initiative, and ability to lead and collaborate depending on the project.
- Flexibility and agility to accommodate constant project changes and time constraints.
- Willing to engage as a member of a global team with members in several different time zones and schedules.
Education required:
- Bachelor’s Degree in Chemistry/Biology/related life science degrees. Master’s Degree preferred
À propos de l’entreprise :
Inspirée par la Méditerranée, Moroccanoil prend vie à travers notre emblématique emballage turquoise et notre fragrance signature, offrant une expérience exotique qui transporte les sens. Notre traitement original Moroccanoil a été le pionnier des soins capillaires infusés à l’huile et a suscité un engouement mondial pour l’huile d’argan. Au cœur de notre marque se trouve la communauté de stylistes qui nous inspire à créer des produits efficaces et faciles à utiliser.
Aujourd’hui, notre mission demeure la même : être à l’avant-garde de l’innovation beauté tout en ayant un impact positif. Nous soutenons le bien-être animal en tant que marque certifiée sans cruauté par PETA grâce à notre certification Beauty Without Bunnies et notre partenariat avec la Humane Society. La conservation des océans et la durabilité sont également essentielles à notre mission, comme en témoigne notre collaboration avec Oceana. Alors que notre parcours se poursuit, nous nous efforçons de faire une différence significative dans nos communautés et à travers le monde.
Exigences
Les principales responsabilités impliquent :
- La réalisation d’examens réglementaires sur des matières premières, formules et emballages pour veiller à la conformité avec l’ensemble des réglementations pertinentes avec une attention particulière pour la FDA des É.-U. et Santé Canada, et assurer que tous les produits proposés respectent les normes et réglementations.
- L’étroite collaboration avec les services de Développement de produits et Marketing pour fournir une contribution sur la réglementation pour les projets liés aux nouveaux développements ou aux modifications de produits existants dans le cadre réglementaire et de la conformité.
- Une assistance auprès de l’équipe marketing pour assurer que toutes les propriétés attribuées aux produits sont correctement corroborées, afin de respecter les réglementations.
- L’assurance que tous les protocoles de test des produits respectent les exigences réglementaires ou normes industrielles définies.
- La vérification constante, l’analyse et la réalisation de l’évaluation d’impact sur tous les changements réglementaires dans différents marchés et la communication de cette information aux différents services pertinents, y compris le Développement de produits et la Production, afin de s’assurer que l’entreprise continue de se conformer à toutes les réglementations au fil du temps.
Qualifications:
- 1 à 4 ans d’expérience professionnelle dans un domaine similaire ou pertinent, de préférence dans le secteur des cosmétiques.
- Connaissances des réglementations sur les produits cosmétiques et en vente libre de la FDA aux É.-U., du Food Drug and Cosmetic Act (FD&C), du Fair Packaging and Labeling Act (FPLA), du California Proposition 65 et autres réglementations locales, d’État et fédérales pertinentes.
- Connaissance des réglementations de Santé Canada et du processus de notification.
- Capacité à comprendre et analyser des rapports d’évaluation de la sûreté.
- Connaissance de bases de données INCI mondiales.
- Présenter d’excellentes capacités de communication orale et écrite en anglais (le français et/ou l’hébreu constitue un atout).
- Capacité à prendre des initiatives et à diriger et collaborer selon le projet.
- Flexibilité et agilité pour s’adapter à des modifications constantes de projet et contraintes de temps.
- Envie de s’engager en tant que membre d’une équipe internationale avec des membres dans différents fuseaux horaires et avec différents calendriers.
Formation:
- Baccalauréat en chimie/biologie/diplômes pertinents en sciences de la vie. Niveau maîtrise préféré
Regulatory Affairs Coordinator
Posted 3 days ago
Job Viewed
Job Description
About the Company:
Inspired by the Mediterranean, Moroccanoil comes to life through our iconic turquoise packaging and signature fragrance, for an exotic experience that transports the senses. Our original Moroccanoil Treatment pioneered oil-infused haircare and sparked global interest in argan oil. At the heart of our brand is the stylist community that inspires us to create effective and easy-to-use products.
Today, our mission remains unchanged: to pioneer beauty innovations while making a positive impact. We support animal welfare as a cruelty-free brand with our PETA Beauty without Bunnies certification and partnership with the Humane Society. Ocean conservation and sustainability are central to us, including our collaboration with Oceana. As our journey continues, we strive to make a meaningful difference in our communities and around the world.
Requirements
Key responsibilities involve:
- Performing regulatory reviews on raw materials, formulations and packaging to confirm compliance with all relevant regulations with particular emphasis on US FDA and Health Canada, and ensuring all products offered meet required standards and regulations.
- Working closely with Product Development and Marketing departments to provide regulatory input on projects related to new developments or changes to existing products from the point of view of regulatory framework and compliance.
- Providing support to Marketing team to ensure all product claims are substantiated properly to comply with regulations.
- Ensuring product testing protocols comply with regulatory requirements or defined industry standards.
- Constantly monitoring, analyzing and providing impact assessment on all regulatory changes in different markets and communicates this information with relevant departments including Product Development and Production to ensure company remains complaint with all regulations over time.
Qualifications:
- 1 to 4 years of work experience in similar or relevant field, preferably in the cosmetic industry.
- Knowledge of US FDA cosmetic and OTC products regulations, the Food Drug and Cosmetic Act (FD&C), The Fair Packaging and Labeling Act (FPLA), California Prop 65 and other relevant local, state and federal regulations.
- Knowledge of Health Canada regulations and notification process.
- Ability to understand and analyze safety assessment reports.
- Knowledge of global INCI databases.
- Demonstrates excellent verbal and written communications skills in English; French and/or Hebrew an asset.
- Able to take initiative, and ability to lead and collaborate depending on the project.
- Flexibility and agility to accommodate constant project changes and time constraints.
- Willing to engage as a member of a global team with members in several different time zones and schedules.
Education required:
- Bachelor’s Degree in Chemistry/Biology/related life science degrees. Master’s Degree preferred
À propos de l’entreprise :
Inspirée par la Méditerranée, Moroccanoil prend vie à travers notre emblématique emballage turquoise et notre fragrance signature, offrant une expérience exotique qui transporte les sens. Notre traitement original Moroccanoil a été le pionnier des soins capillaires infusés à l’huile et a suscité un engouement mondial pour l’huile d’argan. Au cœur de notre marque se trouve la communauté de stylistes qui nous inspire à créer des produits efficaces et faciles à utiliser.
Aujourd’hui, notre mission demeure la même : être à l’avant-garde de l’innovation beauté tout en ayant un impact positif. Nous soutenons le bien-être animal en tant que marque certifiée sans cruauté par PETA grâce à notre certification Beauty Without Bunnies et notre partenariat avec la Humane Society. La conservation des océans et la durabilité sont également essentielles à notre mission, comme en témoigne notre collaboration avec Oceana. Alors que notre parcours se poursuit, nous nous efforçons de faire une différence significative dans nos communautés et à travers le monde.
Exigences
Les principales responsabilités impliquent :
- La réalisation d’examens réglementaires sur des matières premières, formules et emballages pour veiller à la conformité avec l’ensemble des réglementations pertinentes avec une attention particulière pour la FDA des É.-U. et Santé Canada, et assurer que tous les produits proposés respectent les normes et réglementations.
- L’étroite collaboration avec les services de Développement de produits et Marketing pour fournir une contribution sur la réglementation pour les projets liés aux nouveaux développements ou aux modifications de produits existants dans le cadre réglementaire et de la conformité.
- Une assistance auprès de l’équipe marketing pour assurer que toutes les propriétés attribuées aux produits sont correctement corroborées, afin de respecter les réglementations.
- L’assurance que tous les protocoles de test des produits respectent les exigences réglementaires ou normes industrielles définies.
- La vérification constante, l’analyse et la réalisation de l’évaluation d’impact sur tous les changements réglementaires dans différents marchés et la communication de cette information aux différents services pertinents, y compris le Développement de produits et la Production, afin de s’assurer que l’entreprise continue de se conformer à toutes les réglementations au fil du temps.
Qualifications:
- 1 à 4 ans d’expérience professionnelle dans un domaine similaire ou pertinent, de préférence dans le secteur des cosmétiques.
- Connaissances des réglementations sur les produits cosmétiques et en vente libre de la FDA aux É.-U., du Food Drug and Cosmetic Act (FD&C), du Fair Packaging and Labeling Act (FPLA), du California Proposition 65 et autres réglementations locales, d’État et fédérales pertinentes.
- Connaissance des réglementations de Santé Canada et du processus de notification.
- Capacité à comprendre et analyser des rapports d’évaluation de la sûreté.
- Connaissance de bases de données INCI mondiales.
- Présenter d’excellentes capacités de communication orale et écrite en anglais (le français et/ou l’hébreu constitue un atout).
- Capacité à prendre des initiatives et à diriger et collaborer selon le projet.
- Flexibilité et agilité pour s’adapter à des modifications constantes de projet et contraintes de temps.
- Envie de s’engager en tant que membre d’une équipe internationale avec des membres dans différents fuseaux horaires et avec différents calendriers.
Formation:
- Baccalauréat en chimie/biologie/diplômes pertinents en sciences de la vie. Niveau maîtrise préféré
Regulatory Affairs Coordinator
Posted 3 days ago
Job Viewed
Job Description
About the Company:
Inspired by the Mediterranean, Moroccanoil comes to life through our iconic turquoise packaging and signature fragrance, for an exotic experience that transports the senses. Our original Moroccanoil Treatment pioneered oil-infused haircare and sparked global interest in argan oil. At the heart of our brand is the stylist community that inspires us to create effective and easy-to-use products.
Today, our mission remains unchanged: to pioneer beauty innovations while making a positive impact. We support animal welfare as a cruelty-free brand with our PETA Beauty without Bunnies certification and partnership with the Humane Society. Ocean conservation and sustainability are central to us, including our collaboration with Oceana. As our journey continues, we strive to make a meaningful difference in our communities and around the world.
Requirements
Key responsibilities involve:
- Performing regulatory reviews on raw materials, formulations and packaging to confirm compliance with all relevant regulations with particular emphasis on US FDA and Health Canada, and ensuring all products offered meet required standards and regulations.
- Working closely with Product Development and Marketing departments to provide regulatory input on projects related to new developments or changes to existing products from the point of view of regulatory framework and compliance.
- Providing support to Marketing team to ensure all product claims are substantiated properly to comply with regulations.
- Ensuring product testing protocols comply with regulatory requirements or defined industry standards.
- Constantly monitoring, analyzing and providing impact assessment on all regulatory changes in different markets and communicates this information with relevant departments including Product Development and Production to ensure company remains complaint with all regulations over time.
Qualifications:
- 1 to 4 years of work experience in similar or relevant field, preferably in the cosmetic industry.
- Knowledge of US FDA cosmetic and OTC products regulations, the Food Drug and Cosmetic Act (FD&C), The Fair Packaging and Labeling Act (FPLA), California Prop 65 and other relevant local, state and federal regulations.
- Knowledge of Health Canada regulations and notification process.
- Ability to understand and analyze safety assessment reports.
- Knowledge of global INCI databases.
- Demonstrates excellent verbal and written communications skills in English; French and/or Hebrew an asset.
- Able to take initiative, and ability to lead and collaborate depending on the project.
- Flexibility and agility to accommodate constant project changes and time constraints.
- Willing to engage as a member of a global team with members in several different time zones and schedules.
Education required:
- Bachelor’s Degree in Chemistry/Biology/related life science degrees. Master’s Degree preferred
À propos de l’entreprise :
Inspirée par la Méditerranée, Moroccanoil prend vie à travers notre emblématique emballage turquoise et notre fragrance signature, offrant une expérience exotique qui transporte les sens. Notre traitement original Moroccanoil a été le pionnier des soins capillaires infusés à l’huile et a suscité un engouement mondial pour l’huile d’argan. Au cœur de notre marque se trouve la communauté de stylistes qui nous inspire à créer des produits efficaces et faciles à utiliser.
Aujourd’hui, notre mission demeure la même : être à l’avant-garde de l’innovation beauté tout en ayant un impact positif. Nous soutenons le bien-être animal en tant que marque certifiée sans cruauté par PETA grâce à notre certification Beauty Without Bunnies et notre partenariat avec la Humane Society. La conservation des océans et la durabilité sont également essentielles à notre mission, comme en témoigne notre collaboration avec Oceana. Alors que notre parcours se poursuit, nous nous efforçons de faire une différence significative dans nos communautés et à travers le monde.
Exigences
Les principales responsabilités impliquent :
- La réalisation d’examens réglementaires sur des matières premières, formules et emballages pour veiller à la conformité avec l’ensemble des réglementations pertinentes avec une attention particulière pour la FDA des É.-U. et Santé Canada, et assurer que tous les produits proposés respectent les normes et réglementations.
- L’étroite collaboration avec les services de Développement de produits et Marketing pour fournir une contribution sur la réglementation pour les projets liés aux nouveaux développements ou aux modifications de produits existants dans le cadre réglementaire et de la conformité.
- Une assistance auprès de l’équipe marketing pour assurer que toutes les propriétés attribuées aux produits sont correctement corroborées, afin de respecter les réglementations.
- L’assurance que tous les protocoles de test des produits respectent les exigences réglementaires ou normes industrielles définies.
- La vérification constante, l’analyse et la réalisation de l’évaluation d’impact sur tous les changements réglementaires dans différents marchés et la communication de cette information aux différents services pertinents, y compris le Développement de produits et la Production, afin de s’assurer que l’entreprise continue de se conformer à toutes les réglementations au fil du temps.
Qualifications:
- 1 à 4 ans d’expérience professionnelle dans un domaine similaire ou pertinent, de préférence dans le secteur des cosmétiques.
- Connaissances des réglementations sur les produits cosmétiques et en vente libre de la FDA aux É.-U., du Food Drug and Cosmetic Act (FD&C), du Fair Packaging and Labeling Act (FPLA), du California Proposition 65 et autres réglementations locales, d’État et fédérales pertinentes.
- Connaissance des réglementations de Santé Canada et du processus de notification.
- Capacité à comprendre et analyser des rapports d’évaluation de la sûreté.
- Connaissance de bases de données INCI mondiales.
- Présenter d’excellentes capacités de communication orale et écrite en anglais (le français et/ou l’hébreu constitue un atout).
- Capacité à prendre des initiatives et à diriger et collaborer selon le projet.
- Flexibilité et agilité pour s’adapter à des modifications constantes de projet et contraintes de temps.
- Envie de s’engager en tant que membre d’une équipe internationale avec des membres dans différents fuseaux horaires et avec différents calendriers.
Formation:
- Baccalauréat en chimie/biologie/diplômes pertinents en sciences de la vie. Niveau maîtrise préféré
Senior Manager Regulatory Affairs
Posted today
Job Viewed
Job Description
At Momentum Financial Services Group, we help people move forward by reimagining how money works for those who need it most. With more than 40 years of experience, we're the team behind Money Mart-Canada's largest non-bank branch network-and a leader in financial solutions for underserved communities.
From short-term loans to money transfers and prepaid cards, we power the products, technology, and operations that connect over a million customers a year to the money they need, when they need it.
At MFSG, we come together across teams and departments to create something bigger than ourselves: solutions that remove barriers and give people access to money they might not get anywhere else. Whether you're solving problems, building systems, or shaping strategy, your work fuels real support for real people.
We've Got You Covered
Compensation Philosophy: Our strategy is simple-we aim to match the market. We regularly review industry standards to ensure our total rewards package is competitive and fair. This commitment helps us attract and retain talented individuals who share our purpose.
Discretionary Annual Bonus: Enjoy the opportunity for a discretionary bonus based on individual performance and company success.
Comprehensive Benefits: Our benefits include health and dental plans with 100% of the premiums covered. We also offer an Employee Assistance Program to support your mental well-being and provide resources for personal challenges.
Retirement Plans: Plan for your future with our robust retirement savings options, ensuring you're set for the long haul.
Hybrid Work Environment: Experience the best of both worlds with our hybrid work model, allowing you to balance remote work with in-office. When you're at our corporate head office, enjoy a relaxed and collaborative environment featuring breakout rooms for brainstorming and unwinding, plus a variety of snacks to keep you energized throughout the day.
Perks and Rewards: Enjoy reimbursement for tuition assistance and professional development, discounts through Perkopolis and participate in our rewards and recognition programs to celebrate your contributions.
The Job: Senior Manager, Regulatory Affairs
We're looking for a strategic and politically astute Senior Manager, Regulatory Affairs to lead and coordinate our legislative, regulatory, and policy advocacy efforts across Canada and the U.S. If you understand government policy related to consumer lending and money services, and can navigate complex regulatory environments while influencing outcomes-this role is for you. You'll serve as a critical bridge between public policy and internal strategy, managing external relationships and shaping the legal and reputational landscape in which we operate.
What You'll Do:
Monitor and Assess: Track proposed legislation, regulations, and political developments across federal, provincial, and state levels, providing insights to internal stakeholders.
Communicate and Advise: Draft policy briefings, comment letters, and strategic assessments. Guide internal teams and senior leaders on regulatory trends, risks, and opportunities.
Build Relationships: Manage relationships with legislators, regulators, and government officials. Represent the company in trade associations and industry working groups.
Drive Strategy: Identify emerging policy risks and areas for advocacy. Support decision-making related to business risk, compliance, market entry/exit, and strategic planning.
Ensure Compliance: Maintain lobbying registrations and regulatory reporting. Oversee external consultants and legal advisors to ensure alignment and efficiency.
Coordinate Internally: Facilitate internal communication on high-risk political or regulatory issues. Collaborate with Legal, Compliance, Risk, Product, and Communications teams.
What You'll Bring to the Table:
Policy and Regulatory Expertise: In-depth knowledge of Canadian and U.S. legislative and regulatory processes, particularly as they relate to consumer lending and money service businesses.
Political Acumen: You understand the strategic dynamics of public policy, including interest rate caps, AML/ATF regimes, consumer protection, and reputational risk.
Exceptional Communicator: Strong written and verbal communication skills, with a proven ability to simplify complex policy matters for various audiences.
Relationship Builder: Skilled at maintaining productive relationships with government, industry, and internal stakeholders.
Detail-Oriented and Strategic: You balance analytical rigor with sound judgment and operate effectively in high-visibility, fast-paced environments.
Integrity and Discretion: You're trusted to handle sensitive matters with professionalism, confidentiality, and political sensitivity.
Education + Experience:
Bachelor's degree in Political Science, Public Policy, Law, or a related field
5-8 years of experience in government relations, public policy, law, or regulatory affairs
Experience in consumer finance, fintech, or regulated services preferred
Policy experience across both Canada and the U.S. strongly preferred
Ready to make an impact? If you're excited to bring your skills to a company that's changing the game, we'd love to have you onboard. Apply today and let's build the future of MFSG, together!
Senior Director Regulatory Affairs
Posted 3 days ago
Job Viewed
Job Description
Introduction
We are currently hiring a Senior Director, Drug Development & Regulatory Strategy for our client, a growing, mission-driven organization in the drug development space. This company focuses on helping bring new therapies to market—faster and smarter—by guiding early-stage drug programs through regulatory milestones.
In this senior leadership position, you’ll oversee regulatory strategy and operations for early-stage drug development, with a focus on first-in-human and first-in-class molecules. You'll manage a talented Regulatory Affairs team and serve as the main point of contact for global health authorities (FDA, Health Canada, EMA).
Responsibilities
- Shape and lead regulatory strategy for early development programs
- Consult with clients during pre-award phase to define regulatory needs
- Lead regulatory content for proposals and client meetings
- Manage and mentor a high-performing regulatory team
- Serve as main liaison with regulatory agencies (FDA, Health Canada, EMA)
- Guide preparation for regulatory meetings (e.g. pre-IND, pre-CTA)
- Oversee submission content for INDs, CTAs, and other filings
- Partner with internal teams across Clinical, CDMO, Medical Writing, and Project Management
- Monitor changing regulations and industry trends
- Implement best practices and SOPs for compliance and efficiency
Requirements
- Advanced degree in life sciences or regulatory-related discipline (PhD preferred)
- 10+ years of Global Regulatory Affairs experience in a CRO, biotech, or pharma environment
- Proven track record leading early-stage regulatory strategy and submissions
- Strong knowledge of FDA and Health Canada requirements (IND, CTA)
- Excellent communication and cross-functional leadership skills
- Sound scientific and business judgment
- Understanding of GMP, GLP, and GCP practices
What We Offer
Why apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. We will get you going while you get on with the job.
About Us
Brunel has a reputation for working with some of the best in the business. That is what we continually strive for. Over 45 years, we have created a global network of interesting clients and talented individuals working together through a vast array of services.
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