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Regulatory Affairs Specialist, Chemistry and Manufacturing

3 months ago

Montreal, Quebec, Canada Pharmascience Full time
Job Summary

The Regulatory Affairs Specialist, Chemistry and Manufacturing will assume responsibilities within the department to ensure the 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 and OTC drugs, natural health products, and biologics, as well as medical devices.
  • Manage the preparation of high-quality regulatory submissions, including evaluation of data, regulatory strategy, and project coordination according to predefined timelines.
  • Ensure 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 liaise with corporate partners and provide 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.
  • 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.