Strategic Regulatory Manager

5 days ago


SaintProsperdeDorchester QC, Canada Advanced Clinical Part time
About the Role
This part-time position will be based in Canada and requires a highly skilled Regulatory Affairs professional to join our team. As a key member of our organization, you will contribute to the development and growth of our regulatory affairs service provision, collaborating across departments and establishing and maintaining client relationships.

In this role, you will be responsible for managing regulatory agency submissions (eCTD, IND applications, Clinical Trial, NDAs, BLAs, MAA's, Amendments, Variations, Renewals), monitoring emerging trends within the global regulatory environment, and communicating assessments of business impact to internal and external stakeholders. You will also review and provide feedback on SOPs, educate colleagues on regulatory policies and practices, and provide guidance to business leadership to optimize strategies across functional areas.

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