About the Company
Bausch Health Canada is a leading global pharmaceutical company committed to improving people’s lives through our healthcare products. With a strong focus on eye health, gastroenterology, and dermatology, we develop, manufacture, and market a broad array of branded, generic, and over-the-counter products. Our Canadian operations play a crucial role in our global strategy, ensuring access to essential medicines and health solutions across the nation and beyond.
Job Description
We are seeking an experienced and highly motivated Regulatory Affairs Manager to join our dynamic team in Mount Pearl, NL. This critical role is responsible for ensuring the timely preparation, submission, and approval of regulatory applications for our diverse portfolio of pharmaceutical and medical device products in Canada. The successful candidate will navigate complex regulatory landscapes, provide strategic guidance, and ensure full compliance with all health authority regulations. We are proud to offer international sponsorship for qualified candidates looking to build a career with us in Canada.
Key Responsibilities
- Manage the preparation, submission, and maintenance of regulatory applications (e.g., NDS, ANDS, CTA, MDL, Class II-IV Medical Device Licenses) to Health Canada and other relevant regulatory bodies.
- Provide strategic regulatory guidance and support to cross-functional teams including R&D, Clinical, Medical, Marketing, and Quality Assurance throughout the product lifecycle.
- Act as the primary liaison with Health Canada for assigned products, managing inquiries and commitments.
- Monitor and interpret new and evolving Canadian and international regulatory requirements, assessing their impact on company products and operations.
- Develop and implement robust regulatory strategies to facilitate product approvals and maintain compliance.
- Oversee the review of promotional materials and labeling to ensure adherence to regulatory guidelines.
- Lead and mentor junior regulatory affairs professionals.
- Participate in due diligence activities for new product acquisitions and licensing opportunities.
Required Skills
- Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology, Life Sciences).
- Minimum of 60 months (5 years) of progressive experience in Regulatory Affairs within the pharmaceutical or medical device industry in Canada.
- Thorough knowledge of Health Canada regulations and guidelines (e.g., Food and Drugs Act and Regulations, Medical Devices Regulations).
- Proven experience with eCTD submissions and electronic publishing tools.
- Strong project management and organizational skills with the ability to manage multiple priorities in a fast-paced environment.
- Excellent written and verbal communication skills in English.
- Demonstrated ability to work independently and collaboratively in a team setting.
- Strong analytical and problem-solving abilities.
Preferred Qualifications
- Master's degree or Ph.D. in a relevant scientific field.
- Regulatory Affairs Certification (RAC) or equivalent.
- Experience with international regulatory submissions (e.g., FDA, EMA) is an asset.
- Familiarity with Quality Management Systems (e.g., ISO 13485, GMP).
Perks & Benefits
- Competitive annual salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and holiday schedule.
- Defined contribution pension plan with company matching.
- Opportunities for professional development and continuous learning.
- Relocation assistance and international sponsorship for eligible candidates.
- Employee wellness programs.
- Modern office environment with state-of-the-art facilities.
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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