Regulatory Affairs Specialist

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 - 9 to 12 months

Job Description

Key Responsibilities:

• 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), health canada, Regulatory Affairs