Regulatory Affairs Specialist

1 month ago


Montreal, Quebec, Canada Pharmascience Inc. Full time

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pharmascience Inc. The successful candidate will be responsible for ensuring the timely and compliant maintenance of products and participating in various regulatory projects with corporate partners in Europe.

Key Responsibilities

  • Assume 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.
  • 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 (e.g., Business Development, Operations, Marketing, etc.). Ensure the efficient and accurate maintenance of essential regulatory documents and data.

Requirements

  • 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.
  • Good knowledge of international regulations.
  • 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 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.

Qualifications

  • Required: Bachelor or better in Science or related field.
  • Required: 1-3 years experience in the pharmaceutical industry with direct experience with good manufacturing practices.


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