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Vice President, CMC Regulatory Affairs; Fully Remote
Remote / Online - Candidates ideally in
Philadelphia, Philadelphia County, Pennsylvania, 19113, USA
Listed on 2026-11-01
Philadelphia, Philadelphia County, Pennsylvania, 19113, USA
Listing for:
Kailera Therapeutics
Full Time, Remote/Work from Home
position Listed on 2026-11-01
Job specializations:
-
Management
Regulatory Compliance Specialist -
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
- Lead CMC Regulatory Affairs and provide strategic leadership.
- Report to SVP of Regulatory and shape global CMC strategy.
Key Responsibilities:
- Develop and own global CMC regulatory strategy, including Phase 3 readiness.
- Serve as lead CMC voice with FDA, EMA, and other health authorities.
- Build, lead, and develop a high-performing CMC Regulatory team.
Qualifications & Benefits:
- 15+ years biopharma experience with 10+ years in Regulatory CMC.
- Proven track record of successful FDA and EMA submissions.
- Salary range $272,000 - $340,000 USD with comprehensive health coverage and flexible time off.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.
We are seeking a motivated Vice President, CMC Regulatory Affairs (Fully Remote) to join Kailera Therapeutics in United States.
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