Vice President, CMC Regulatory Affairs; Fully Remote

• 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.