173 Regulatory Affairs Experts jobs in Canada

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Regulatory Affairs Group
**Job Sub** **Function:**
Regulatory Affairs
**Job Category:**
People Leader
**All Job Posting Locations:**
Toronto, Ontario, Canada
**Job Description:**
**About Innovative Medicine**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at are searching for the best talent for our Director, Regulatory Affairs position, to be located in Toronto, Ontario under the flexible working model (at least 3 days in office).**
The Director, Regulatory Affairs provides leadership and direction for the development and execution of innovative approaches in assigned therapeutic area(s), to drive business growth in compliance with Canadian Drug Laws and Regulations, and corporate policies and procedures. The Director will lead a team of regulatory professionals to achieve strategic priorities, ensuring robust registration strategies for our pipeline medicines, and optimal outcomes for new indications/line extensions throughout the product lifecycle. As a subject matter authority on Regulatory Affairs, the Director will provide guidance to local and global business partners.
Accountabilities
+ Lead and mentor a team of regulatory professionals (therapeutic and Chemistry, Manufacturing & Controls (CMC)) to deliver business objectives through development of innovative regulatory strategies implemented in close collaboration with local and global teams.
+ Build a Regulatory Affairs talent pipeline through the selection and development of employees.
+ Understand global regulatory trends and policies that would impact the Canadian regulatory environment.
+ Shape Health Canada policies to achieve a positive regulatory environment for pipeline and marketed products.
+ Coordinate management of emerging issues (e.g. new safety or quality findings) and associated risk communications.
+ Ensure systems/processes support company policies and regulatory requirements and sponsor initiatives to improve the work environment.
+ Collaborate with the Global Regulatory Affairs (GRA) function to advocate for Canadian needs.
+ Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business portfolio priorities.
+ Develop effective working relationships with opinion leaders as needed.
+ Budget and resource planning.
Essential Skills/Experience
+ Minimum M.Sc. in Biological or related sciences. Advanced degree preferred.
+ 10+ years pharmaceutical Regulatory Affairs or related experience, including major Health Authority Interactions.
+ Previous people management experience with success in developing and empowering teams
Core/Technical Proficiency Requirements
+ Strong medical and scientific understanding of clinical trials, biostatistics, and drug development
+ Solid knowledge of Canadian drug laws, regulations, guidelines and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions
+ Ability to interpret and understand laws, regulations, guidances and polices in the context of the scientific and commercial environments.
+ Excellent collaborator and teammate
+ Strong interpersonal and communication skills with persuasive ability to influence and negotiate with key customers (e.g., Health Canada, local and global business partners)
+ Strong business insight, with excellent customer and market place focus
+ Strong scientific writing skills
+ Excellent problem solving and critical thinking skills
+ Proven leadership skills including coaching/mentoring and motivating a team, to enable teamwork, innovation and problem-solving
+ Self-motivated - sense of urgency, initiative and ability to balance multiple priorities
+ Outstanding Strategic and decision-making skills
#LI-Hybrid

Job Description

Job Description

Job Title: Director, Regulatory Affairs

Location: Greater Vancouver, BC
Industry: In Vitro Diagnostics (IVD) / MedTech
Type: Full-Time | On-site
Reports To: Executive Leadership
Salary Range: $125,000 to $135,000

About the Company

Our client is a growing IVD company recognized for advancing diagnostic accuracy and regulatory excellence. Headquartered in Greater Vancouver, the company is expanding globally with a strong focus on quality and compliance.

Position Overview

The Director, RA will lead regulatory strategy and team activities for IVD products across global markets, ensuring successful submissions and ongoing compliance with international standards. This role includes mentoring staff and aligning regulatory efforts with R&D, operations, and commercial functions.

Key Responsibilities

• Lead regulatory strategy and team for IVD products across global markets.

• Direct submissions and serve as primary liaison with FDA, Health Canada, and EU Notified Bodies.

• Ensure QMS compliance with ISO 13485, MDSAP, and international standards.

• Provide clinical oversight support as required.

• Provide customer support as required.

• Monitor evolving regulations and update policies and processes as needed.

Qualifications

• MSc in a scientific or engineering field, or equivalent experience.

• 5+ years IVD regulatory experience with FDA, Health Canada, and EU IVDR.

• Proven expertise in global submissions and compliance programs.

• Demonstrated leadership managing teams in a mid-sized company.

• Strong cross-functional collaboration skills.

• Must have legal authority to work in Canada.

Why Join

This is an opportunity to lead regulatory affairs in a dynamic IVD company with an innovative pipeline and supportive leadership, while making a global impact on diagnostic healthcare.

#TSSHP LI-TS1

#LI-TS1

Job Posting ID: #

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn''t just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.
**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.

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn''t just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.
**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**
**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.