Sr. Director, Regulatory CMC
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-09-21
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-21
Job specializations:
-
Healthcare
-
Pharmaceutical
Job Description & How to Apply Below
Role:
Senior Director of Regulatory CMC responsible for global lifecycle management of approved and late-stage gene therapy products, focusing on post-approval activities, change management, and regulatory compliance.
Responsibilities:- develop and execute strategies for post-approval submissions (supplements, variations, annual reports)
- oversee change management for manufacturing and analytical processes
- lead interactions with health authorities (FDA, EMA)
- ensure inspection readinessmentor the Regulatory CMC team
- Bachelor's or Master's in life sciences
- minimum 15 years in biopharma with extensive post-approval CMC experience in cell and gene therapies
- proven track record leading regulatory submissions and inspections
- in-depth knowledge of GMP, CMC regulations, and global frameworks
- PhD
- strong leadership skills
- strategic thinking
- experience supporting commercial manufacturing of complex biologics or gene therapies
- extensive post-approval CMC lifecycle expertise
- gene therapy focus
- regulatory leadership in a global context
- cross-functional collaboration
- hybrid in Somerville, MA
- travel details not specified
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