Regulatory Affairs Specialist, Chemistry and Manufacturing
3 weeks ago
The Regulatory Affairs Specialist, Chemistry and Manufacturing assumes responsibilities within the department to ensure the timely and compliant maintenance of products. The position participates in various regulatory projects with corporate partners in Europe.
Key Responsibilities:
- Maintains and ensures regulatory compliance for approved products, including prescription and OTC drugs, natural health products, biologics, and medical devices.
- Manages the preparation of high-quality regulatory submissions, including data evaluation, regulatory strategy, and project coordination according to predefined timelines.
- Ensures that scientific data supporting variations, as well as daily regulatory activities, are in compliance with all relevant regulations, guidelines, and policies for the impacted territories.
- Reviews and approves product labels to ensure compliance with all regulations.
- Liaises with corporate partners and provides regulatory advice to other divisions and/or departments.
Requirements:
- Excellent communication skills in English and French, with the ability to communicate with business partners outside the Province of Quebec.
- Good analytical skills with high-level attention to detail and commitment to accuracy and depth.
- Good knowledge of international regulations.
- Ability to adapt to situations involving changes and take action without having all the information.
- Ability to work independently and interact with various departments and people as needed.
- Good interpersonal skills to effectively function in a fast-paced, people-oriented team environment.
- Good knowledge of Canadian regulations and ability to interpret policies and guidelines.
- Strong scientific knowledge.
- Good project management skills.
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Montreal, Quebec, Canada Pharmascience Full timeThe Regulatory Affairs Specialist assumes key responsibilities to ensure timely and compliant maintenance of products and participates in various regulatory projects with corporate partners in Europe.Key Responsibilities:Responsible for the maintenance and regulatory compliance for approved products for prescription and OTC drugs, natural health products,...
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Montreal, Quebec, Canada Pharmascience Full timeThe Regulatory Affairs Specialist, Chemistry and Manufacturing will assume responsibilities within the department to ensure timely and compliant maintenance of products and participate in various regulatory projects with corporate partners in Europe.Key Responsibilities:Ensure the maintenance and regulatory compliance for approved products for prescription...
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Montreal, Quebec, Canada Pharmascience Full timeThe Regulatory Affairs Specialist, Chemistry and Manufacturing assumes key responsibilities within the department to ensure timely and compliant maintenance of products and participates in various regulatory projects with corporate partners in Europe.Key Responsibilities:Ensures the maintenance and regulatory compliance for approved products for prescription...
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Montreal, Quebec, Canada Pharmascience Full timeThe Regulatory Affairs Specialist, Chemistry and Manufacturing plays a vital role within the department to ensure timely and compliant product maintenance and participates in various regulatory projects with corporate partners in Europe.Job OverviewAssumes responsibility for maintaining regulatory compliance for approved products, including prescription and...
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Montreal, Quebec, Canada Pharmascience Full timeJob DescriptionThe Regulatory Affairs Specialist, Chemistry and Manufacturing assumes key responsibilities within the department to ensure timely and compliant product maintenance. This role participates in various regulatory projects with corporate partners across Europe.Key Responsibilities:Maintains and ensures regulatory compliance for approved...
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