About the Company
Sartorius is a leading international partner of life science research and the biopharmaceutical industry. With our innovative laboratory instruments and consumables, we enable scientists and engineers to achieve their ambitions in the areas of drug discovery and development, and quality assurance. Our integrated solutions support the entire drug development process, from early research to manufacturing. We are committed to fostering a diverse and inclusive environment where innovation thrives, and we welcome global talent to join our mission.
Job Description
We are seeking a highly motivated and experienced Regulatory Affairs Manager with expertise in the pharmaceutical and medical device sectors to join our growing team in Halifax. This critical role is responsible for overseeing and managing all regulatory activities to ensure compliance with global health authority regulations, particularly for products entering the Canadian market, and supporting international registrations. The ideal candidate will possess a deep understanding of regulatory pathways, excellent communication skills, and a proactive approach to problem-solving. This position offers international sponsorship for qualified candidates looking to relocate to Canada.
Key Responsibilities
- Develop and implement regulatory strategies for new and existing products (pharmaceuticals and medical devices) in Canada and other target markets.
- Prepare and submit high-quality regulatory dossiers, applications, and submissions (e.g., NDSs, ANDSs, DINs, MDELs, device licenses) to Health Canada and other relevant regulatory bodies.
- Act as the primary contact point for Health Canada and other regulatory agencies, managing all correspondence and interactions.
- Monitor and interpret global regulatory changes and trends, advising internal teams on potential impacts and necessary adjustments.
- Ensure ongoing compliance with post-market regulatory requirements, including adverse event reporting, product changes, and renewals.
- Collaborate closely with R&D, Quality Assurance, Manufacturing, and Marketing teams to integrate regulatory requirements throughout the product lifecycle.
- Provide expert regulatory guidance and training to internal stakeholders.
- Manage and mentor junior regulatory affairs staff as the team grows.
- Participate in regulatory inspections and audits as required.
Required Skills
- Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical or medical device industry.
- In-depth knowledge of Health Canada regulations (Food and Drugs Act, Medical Devices Regulations, etc.) and global regulatory guidelines (e.g., FDA, EMA, ICH).
- Proven experience in preparing and submitting regulatory dossiers and obtaining product approvals.
- Strong understanding of product development processes and quality systems (e.g., ISO 13485, GMP).
- Excellent written and verbal communication skills in English.
- Strong analytical, organizational, and problem-solving abilities.
- Ability to work independently and collaboratively in a fast-paced environment.
Preferred Qualifications
- Master's degree or Ph.D. in a relevant scientific discipline (e.g., Pharmacy, Life Sciences, Biomedical Engineering).
- Regulatory Affairs Certification (RAC) or equivalent.
- Experience with electronic submission systems.
- Previous experience managing international regulatory projects or submissions.
- Proficiency in additional languages relevant to international markets.
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.
- Relocation assistance and international sponsorship for eligible candidates.
- Professional development and training opportunities.
- Collaborative and inclusive work environment.
- Opportunities for career growth in a global company.
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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