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Remote Senior CMC Regulatory Affairs Expert: Biologics

Remote / Online - Candidates ideally in
Scarborough, Cumberland County, Maine, 04070, USA
Listing for: Parexel
Remote/Work from Home position
Listed on 2026-10-02
Job specializations:
  • Pharmaceutical
    Healthcare Compliance, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 120000 - 180000 USD Yearly USD 120000.00 180000.00 YEAR
Job Description & How to Apply Below

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics to join remotely. You will support regulatory strategy and compliance for drug development across investigational, new, and marketed products for large biopharmaceutical partnerships, ensuring GMP compliance and successful submissions to FDA, EMA, and Health Canada.

You’ll collaborate with manufacturing, quality, and project management teams, develop CMC regulatory strategies, and contribute to product development from

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

Take a moment to read everything above and see whether this role is right for you.

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

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

Position Requirements
10+ Years work experience
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