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Regulatory Affairs Specialist, Chemistry and Manufacturing

2 months ago

Montreal, Quebec, Canada Pharmascience Full time
Job Title: Spécialiste affaires règlementaires, chimie et fabrication

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 collaboration and excellence in regulatory affairs.

Key Responsibilities:
  • Maintain and ensure regulatory compliance for approved products, including prescription and OTC drugs, natural health products, and biologics, as well as medical devices.
  • Prepare high-quality regulatory submissions, including data evaluation, regulatory strategy, and project coordination, adhering to predefined timelines.
  • Ensure scientific data supporting variations and daily regulatory activities comply with all relevant regulations, guidelines, and policies for impacted territories.
  • Review and approve product labels to guarantee compliance with all regulations.
  • Liaise effectively with corporate partners and provide regulatory advice to other divisions and departments.
  • Maintain accurate and efficient regulatory document and data management.
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 and adaptability in situations involving changes.
  • Ability to work independently and interact with various departments and people as needed.
  • Good interpersonal skills, with the ability to function effectively 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 and good project management skills.