VP, CMC Regulatory Affairs — Global Strategy & Leadership

Regulatory Jobs; Waltham (MA); Hybrid; USD 272,000 - 340,000; Full time

Benefits offered by this job

Health benefits

Annual bonus opportunities

Equity grants

Job summary

Kailera Therapeutics, Inc. is seeking a Vice President of CMC Regulatory to lead all aspects of CMC regulatory strategy. This role reports to the SVP of Regulatory and supports Phase 3 readiness and launch planning.

The position requires extensive drug development expertise, with oversight of submissions to global health authorities and a focus on high-quality, timely regulatory deliverables. Hybrid onsite/remote work is available in Waltham, MA area.

Qualifications

• 15+ years of biopharmaceutical industry experience with 10+ years in Regulatory CMC.
• Proven track record of successful submissions to FDA and/or EMA.
• Strong ability to apply scientific principles to assess regulatory issues and analyze data.

Responsibilities

• Develop and own global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
• Serve as lead CMC voice with FDA, EMA, and global health authorities, including meetings and information requests.
• Ensure execution of CMC regulatory strategy with high-quality submissions and cross-functional alignment.
• Lead the CMC Regulatory team, including hiring, coaching, and succession planning.
• Oversee all CMC submission planning and ensure timely, accurate documents.

Skills

Leadership

Regulatory strategy

FDA/EMA submissions

Cross-functional collaboration

Education

BS in Biochem/Biology/Chemistry/Engineering

Advanced degree preferred

Job description

Kailera Therapeutics, Inc. is seeking a Vice President of CMC Regulatory to lead all aspects of CMC regulatory strategy. This role reports to the SVP of Regulatory and supports Phase 3 readiness and launch planning.

The position requires extensive drug development expertise, with oversight of submissions to global health authorities and a focus on high-quality, timely regulatory deliverables. Hybrid onsite/remote work is available in Waltham, MA area.