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Regulatory Affairs Specialist, Chemistry and Manufacturing

2 months ago

Montreal, Quebec, Canada Pharmascience Full time

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 involves collaborating with corporate partners in Europe to participate in various regulatory projects.

Key Responsibilities:

  • Ensure the maintenance and regulatory compliance of approved products for prescription and OTC drugs, natural health products, and biologics, as well as medical devices.
  • Manage the preparation of high-quality regulatory submissions, including data evaluation, regulatory strategy, and project coordination according to predefined timelines.
  • Verify 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.
  • Review and approve product labels to ensure compliance with all regulations.
  • Effectively communicate with corporate partners and provide regulatory advice to other divisions and/or departments.
  • Ensure the efficient and accurate maintenance of essential regulatory documents and data.

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.
  • 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 that will allow the person to effectively function in a fast-paced, people-oriented team environment.
  • Good knowledge of the Canadian regulations and ability to interpret policies and guidelines.
  • Strong scientific knowledge.
  • Good project management skills.