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Regulatory Affairs Specialist, Chemistry and Manufacturing
1 month ago
The Regulatory Affairs Specialist, Chemistry and Manufacturing plays a crucial role in ensuring the timely and compliant maintenance of products within the department. This position participates in various regulatory projects with corporate partners in Europe, driving regulatory excellence and compliance.
Key Responsibilities:
- Maintains and ensures regulatory compliance for approved products, including prescription and OTC drugs, natural health products, and biologics, as well as medical devices.
- Prepares high-quality regulatory submissions, including data evaluation, regulatory strategy, and project coordination, according to predefined timelines.
- Ensures scientific data supporting variations and daily regulatory activities comply with all relevant regulations, guidelines, and policies for impacted territories.
- Reviews and approves product labels to ensure compliance with all regulations.
- Liaises effectively with corporate partners and provides regulatory advice to other divisions and/or departments.
- Maintains essential regulatory documents and data with accuracy and efficiency.
Requirements:
- Excellent communication skills in English and French, with the ability to communicate with business partners outside the Province of Quebec.
- Strong analytical skills with high-level attention to detail and commitment to accuracy and depth.
- Good knowledge of international regulations.
- Adaptability in situations involving changes and the capacity to take action without having all the information.
- Ability to work independently, yet interact with various departments and people as needed.
- Good interpersonal skills to effectively function in a fast-paced, people-oriented team environment.
- Proficiency in using Microsoft suite (including Word, Excel, and PowerPoint) and Adobe.
- Good knowledge of Canadian regulations and ability to interpret policies and guidelines.
- Strong scientific knowledge.
- Good project management skills.
- Knowledge and/or experience in regulatory affairs is an asset.
