About the Company
Vallefield BioPharma Inc. is a rapidly growing pharmaceutical and medical device company based in Salaberry-de-Valleyfield, Quebec. We are dedicated to developing innovative healthcare solutions that improve patient lives. Our commitment to scientific excellence and regulatory compliance drives our success. We foster a diverse and inclusive work environment and are proud to support global talent through international sponsorship.
Job Description
We are seeking a highly motivated and experienced Regulatory Affairs Manager to join our dynamic team in Salaberry-de-Valleyfield. This critical role involves managing regulatory submissions, ensuring compliance with health authority regulations (Health Canada, FDA, EMA, etc.), and providing strategic guidance on product development from a regulatory perspective for pharmaceutical products and medical devices. The ideal candidate will have a strong background in regulatory affairs within the pharma/med sector and be adept at navigating complex international regulatory landscapes. This position offers international sponsorship for qualified candidates.
Key Responsibilities
- Lead and manage the preparation, submission, and maintenance of regulatory filings (e.g., NDS, ANDS, CTA, IND, PMA, 510(k)) to health authorities.
- Develop and implement global regulatory strategies for new and existing products.
- Act as the primary liaison with regulatory agencies during product development and post-market activities.
- Monitor and interpret new and evolving regulatory requirements and communicate their impact to relevant stakeholders.
- Ensure all company operations and products comply with applicable national and international regulations and guidelines.
- Provide regulatory input and guidance to cross-functional teams, including R&D, Clinical, Quality, and Marketing.
- Oversee regulatory aspects of product labeling, advertising, and promotional materials.
- Manage regulatory inspections and audits, ensuring all documentation is accurate and readily available.
Required Skills
- Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical or medical device industry.
- In-depth knowledge of Health Canada, FDA, and/or EMA regulations and guidelines.
- Proven experience in managing regulatory submissions and approvals.
- Strong understanding of product lifecycle management from a regulatory standpoint.
- Excellent written and verbal communication skills in English and French (bilingualism preferred).
- Ability to interpret complex regulations and provide clear, actionable advice.
- Demonstrated leadership and project management capabilities.
- Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology, Life Sciences).
Preferred Qualifications
- Master's degree or Ph.D. in a relevant scientific field.
- Regulatory Affairs Certification (RAC).
- Experience with international regulatory filings beyond North America.
- Familiarity with Quality Management Systems (ISO 13485, GMP).
Perks & Benefits
- Competitive salary and comprehensive benefits package.
- Generous vacation and paid time off.
- Health, dental, and vision insurance.
- Life and disability insurance.
- Retirement savings plan (RRSP) with company match.
- Professional development and continuing education opportunities.
- On-site fitness center and wellness programs.
- International sponsorship and relocation assistance available.
- Employee assistance program.
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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