Strategic CMC Regulatory Leader (VP)

Kailera Therapeutics, Inc.; United States; Hybrid; USD 272,000 - 340,000; Full time

Benefits offered by this job

Health coverage

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus

Job summary

Kailera Therapeutics, Inc. seeks a Vice President of CMC Regulatory to lead all aspects of CMC regulatory strategy as the company advances toward Phase 3.

The role reports to Regulatory leadership and requires extensive drug development expertise in a fast-paced environment at a hub-based or remote work model. Responsibilities include serving as the primary CMC voice with global health authorities, shaping strategy, and building a high-performing team to ensure timely, compliant submissions

Qualifications

• 15+ years in biopharmaceutical industry with 10+ years in Regulatory CMC.
• Proven track record of submissions to FDA/EMA.
• Ability to apply scientific principles to regulatory issues and data.

Responsibilities

• Develop and own global CMC regulatory strategy for portfolio, including Phase 3 readiness and launch planning.
• Lead as CMC voice with FDA, EMA, and other global health authorities; manage meetings and information requests.
• Ensure execution of CMC regulatory strategy and submission quality across functions.
• Build and lead a high-performing CMC Regulatory team; manage org design, hiring and coaching.
• Oversee CMC submission planning/execution within target timelines; liaise across CDMO and external vendors.

Skills

CMC Regulatory leadership

FDA/EMA submissions

Regulatory strategy

Team leadership

Cross-functional collaboration

Education

BS in Biochemistry/Biology/Chemistry/Engineering

Job description

Kailera Therapeutics, Inc. seeks a Vice President of CMC Regulatory to lead all aspects of CMC regulatory strategy as the company advances toward Phase 3.

The role reports to Regulatory leadership and requires extensive drug development expertise in a fast-paced environment at a hub-based or remote work model. Responsibilities include serving as the primary CMC voice with global health authorities, shaping strategy, and building a high-performing team to ensure timely, compliant submissions