More jobs:
Global CMC Regulatory Director Biologics
Job in
Edison, Middlesex County, New Jersey, 08818, USA
Listed on 2026-09-04
Listing for:
PTC Therapeutics, Inc.
Full Time
position Listed on 2026-09-04
Job specializations:
-
Healthcare
Healthcare Compliance -
Pharmaceutical
Healthcare Compliance
Job Description & How to Apply Below
PTC Therapeutics, Inc. is seeking a Director of Regulatory Affairs – CMC to lead the global CMC strategy for biologics, including gene therapies, and to direct preparation of regulatory submission dossiers across INDs/IMPDs and BLA/NDA/MAA programs.
The role works cross-functionally with Regulatory Affairs, Technical Operations, and Quality to ensure timely approvals and lifecycle management. The ideal candidate has 8–10 years in regulatory CMC, strong GMP and ICH knowledge, and the ability to
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