Microsoft Excel Specialist

1 month ago


Montreal, Quebec, Canada Pharmascience Inc. Full time
Job Title: Specialist, Regulatory Affairs

Pharmascience Inc. is seeking a highly skilled Specialist, Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you 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:
  • 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 according to predefined timelines.
  • Ensure that scientific data supporting variations and 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.
  • Liaise with corporate partners and provide regulatory advice to other divisions and/or departments, ensuring 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, with 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, with the ability to effectively function in a fast-paced, people-oriented team environment.
  • Good knowledge of Canadian regulations and 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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