Regulatory Affairs Specialist

6 days ago


Montreal, Canada Healthcare Businesswomen’s Association Full time

Job Description Summary

Location: Montreal, #LI-Hybrid

About the role:
The role reports to Regulatory Affairs Franchise Lead and will work with different team members.

Temporary - 14 months

Job Description

Key Responsabilities:

  • Assists in the preparation of and/or review of various regulatory submissions for new or marketed products and ensures optimal approval conditions and labelling.
  • Prepares Clinical Trial Applications and ensure timely submission to, and authorization from Health Canada.
  • Assists in the preparation of Canadian development/registration strategies in conjunction with other cross-functional team members.
  • Ensures that submissions are accurate, complete and compliant with regulatory requirements.
  • Maintains high quality and professional interactions with Health Canada.
  • Evaluates proposed changes to marketed products for regulatory impact and liaises with internal stakeholders to assemble necessary documentation.
  • Completes other Regulatory Affairs duties as required to ensure compliance with Canadian requirements.

Essential Requirements:

  • At least 1 years of Regulatory Affairs experience in the Pharmaceutical Industry.
  • Bachelor’s degree in science or in a related discipline.
  • Good knowledge of Health Canada regulations, policies and guidelines related to drug submissions.
  • Fluency in English as a business language; bilingualism (English and French) is a strong asset.
  • Good interpersonal, communication and time management skills.

Skills Desired

bilingual (french/english), Drug Regulatory Affairs, health canada, Regulatory Affairs Compliance #J-18808-Ljbffr

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