VP, CMC Regulatory — Global Strategy & Phase 3 Readiness

Kailera Therapeutics, Inc.; Waltham (MA); Hybrid; USD 272,000 - 340,000; Full time

Benefits offered by this job

Health coverage

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 affairs. The role reports to the Senior Vice President of Regulatory and supports Phase 3 readiness, regulatory strategy, and global interactions with health authorities.

The position is hub-based onsite in Waltham, MA part of the time, with remote work options available. Responsibilities include directing regulatory strategy, leading submissions to FDA/EMA, and building a

Qualifications

• 15+ years in biopharmaceutical industry with 10+ years in Regulatory CMC.
• Demonstrated track record of successful submissions to FDA and other health authorities including EMA.
• Ability to apply scientific principles to assess regulatory issues and draw conclusions.
• Strong leadership and ability to motivate teams in a fast-paced environment.
• Excellent verbal and written communication; ability to influence others.

Responsibilities

• Develop and own the global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
• Lead CMC interactions with FDA, EMA, and other health authorities (End-of-Phase 2, pre-submission, Scientific Advice).
• Ensure execution of CMC regulatory strategy and high-quality submissions; manage timelines.

Skills

Regulatory leadership

FDA submissions

Cross-functional leadership

Education

BS degree in Biochemistry, Biology, Chemistry, Engineering or related field

Job description

Kailera Therapeutics, Inc. is seeking a Vice President of CMC Regulatory to lead all aspects of CMC regulatory affairs. The role reports to the Senior Vice President of Regulatory and supports Phase 3 readiness, regulatory strategy, and global interactions with health authorities.

The position is hub-based onsite in Waltham, MA part of the time, with remote work options available. Responsibilities include directing regulatory strategy, leading submissions to FDA/EMA, and building a