About the Company
Novartis Canada is a leading global healthcare company committed to reimagining medicine to improve and extend people’s lives. We use innovative science and digital technologies to create transformative treatments in areas of great medical need. With a strong presence in Canada, we are dedicated to fostering a diverse and inclusive environment where our associates can thrive and contribute to our mission.
Job Description
We are seeking an experienced and dynamic Regulatory Affairs Manager to join our growing team in Saint-Jerome, Quebec. This pivotal role involves managing all aspects of regulatory submissions, compliance, and strategy for our pharmaceutical and medical device products, with a particular focus on navigating international regulatory landscapes. We are proud to offer international sponsorship for highly qualified candidates, demonstrating our commitment to attracting global talent. The successful candidate will be responsible for ensuring our products meet all national and international regulatory requirements, facilitating timely market access, and maintaining our reputation for excellence and integrity.
Key Responsibilities
- Lead and manage the preparation, submission, and maintenance of regulatory dossiers for pharmaceutical and medical device products.
- Develop and implement regulatory strategies to ensure timely approval and market access for new and existing products globally.
- Act as the primary liaison with regulatory authorities (e.g., Health Canada, FDA, EMA) for all assigned projects.
- Monitor and interpret national and international regulatory changes and trends, assessing their impact on company products and operations.
- Ensure compliance with all applicable regulations, guidelines, and company procedures.
- Provide expert regulatory guidance and support to cross-functional teams including R&D, Clinical, Quality, and Marketing.
- Manage post-market surveillance activities and handle regulatory queries or inspections.
- Support due diligence activities for potential partnerships or acquisitions from a regulatory perspective.
Required Skills
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or medical device industry.
- In-depth knowledge of national and international regulatory requirements (e.g., Health Canada, FDA, EMA, ICH guidelines).
- Proven track record of successful regulatory submissions and approvals.
- Strong understanding of product lifecycle management in a regulated environment.
- Excellent communication, negotiation, and interpersonal skills.
- Ability to work independently and as part of a diverse, global team.
- Proficiency in English; French language skills are a strong asset.
- Bachelor's degree in a life science, pharmacy, or related field.
Preferred Qualifications
- Master's degree or Ph.D. in a relevant scientific discipline.
- RAC (Regulatory Affairs Certification).
- Experience with biologics or complex medical devices.
- Demonstrated experience in a leadership or mentorship role.
- Fluency in French.
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and holidays.
- Retirement savings plan with company match.
- Opportunities for professional development and continuing education.
- Employee assistance program.
- Hybrid work model promoting work-life balance.
- International sponsorship for eligible candidates.
- On-site fitness center and wellness programs (where applicable).
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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