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Remote CMC Regulatory Strategist, Biologics

Remote / Online - Candidates ideally in
Scarborough, Cumberland County, Maine, 04070, USA
Listing for: Parexel
Full Time, Remote/Work from Home position
Listed on 2026-11-06
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist, Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 120000 - 165000 USD Yearly USD 120000.00 165000.00 YEAR
Job Description & How to Apply Below

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity based. The role provides CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products to support US, EU, and Canada approvals.

You will prepare and review CMC/GMP documentation, collaborate with manufacturing, quality, and external partners, and contribute to global regulatory strategy from development through post-approval changes.

We are currently recruiting a Remote CMC Regulatory Strategist, Biologics for our team in Augusta, ME, United States.

This posting is for the Remote CMC Regulatory Strategist, Biologics role at Parexel, based in Augusta, ME, United States.

We are looking to fill the Remote CMC Regulatory Strategist, Biologics position at Parexel in Augusta, ME, United States.

The Remote CMC Regulatory Strategist, Biologics role at Parexel is now open for applications in Augusta, ME, United States.

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