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Senior CMC Regulatory Strategy Consultant — Biologics

Job in Vaughan, Ontario, Canada
Listing for: Parexel International
Full Time position
Listed on 2026-09-01
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist
Job Description & How to Apply Below

Parexel International is seeking a CMC Strategy Senior / Regulatory Affairs Consultant to drive global regulatory strategies for biologics and vaccines. You will partner with a client team to lead post-approval activities and lifecycle maintenance across development and commercial products.

You will author and review CMC documentation, perform gap analyses, and guide submissions from planning to execution. Strong cross-functional collaboration and global regulatory knowledge are essential.

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Position Requirements
10+ Years work experience
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