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Specialist CMC, Regulatory Affairs

3 months ago

Montreal Quebec GF, CA Pharmascience Inc. Full time

The Specialist, Regulatory Affairs assumes responsibilities within the department to ensure the timely and compliant maintenance of products and participates to various regulatory projects with corporate partners.

Tasks & Responsibilities

  • Assumes responsibility 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.
  • Effectively liaises with corporate partners and provides regulatory advice to other divisions and/or departments (e.g., Business Development, Operations, Marketing, etc.). Ensures the efficient and accurate maintenance for essential regulatory documents and data.

Skills, Knowledge and Abilities:

  • Excellent communication skills across different audiences in English and French. The position requires communication with business partners outside the Province of Quebec.
  • Good analytical skills with high-level attention to detail and commitment to accuracy and depth.
  • Adaptability in situations involving changes as well as the capacity to take action without having all the information. The Specialist will be able to handle multiple projects at a time.
  • Ability to work independently, yet interact with various departments and people as needed. Must demonstrate the ability to determine, initiate and complete tasks.
  • Good interpersonal skills that will allow the person to effectively function in a fast-paced, people-oriented, team environment. Demonstrated proficiency in using Microsoft suite (including Word, Excel and PowerPoint) and Adobe.
  • Good knowledge of the Canadian regulations as well as the ability to interpret policies and guidelines.
  • Strong scientific knowledge.
  • Good knowledge and/or experience in regulatory affairs is an asset.
QualificationsEducation

Required: Bachelor or better in Science or related field.

Experience

Required: 2-5 years experience in the pharmaceutical industry with direct experience with good manufacturing practices.

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