Regulatory Affairs Specialist with Expertise in Chemistry and Manufacturing

3 days ago

Montreal, Quebec, Canada Pharmascience Full time

The 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, and biologics, as well as medical devices.
  • Manages the preparation of high-quality regulatory submissions, including evaluation of data, 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.
  • Provides regulatory advice to other divisions and/or departments.

Requirements:

  • Excellent communication skills across different audiences in English and French.
  • Good analytical skills with high-level attention to detail and commitment to accuracy and depth.
  • Good knowledge of international regulations.
  • 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.

This role is ideal for a seasoned Regulatory Affairs Specialist with expertise in chemistry and manufacturing. The successful candidate will be able to effectively liaise with corporate partners and provide regulatory advice to other divisions and/or departments.

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