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Role Overview:
- 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
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.