Global CMC Regulatory Strategy Lead

Kailera Therapeutics; 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 and life insurance

Equity grants

Job summary

Kailera Therapeutics in the United States is seeking a Vice President of CMC Regulatory to lead all aspects of CMC regulatory strategy at a pivotal Phase 3 planning stage. The role reports to the Senior VP of Regulatory and requires extensive drug development expertise and a track record with FDA/EMA submissions.

The successful candidate will build and lead a high-performing CMC team, manage global submissions, and partner with QA/Manufacturing to ensure regulatory readiness for launch while

Qualifications

• 15+ years in biopharmaceutical industry with 10+ years in Regulatory CMC.
• Proven track record of FDA/EMA submissions and interactions.
• Ability to lead, motivate and influence cross-functional teams.
• Strong written and verbal communication in a fast-paced environment.

Responsibilities

• Develop and own the global CMC regulatory strategy for the portfolio, including Phase 3 readiness.
• Serve as lead CMC voice with FDA, EMA and other health authorities.
• Ensure successful execution of CMC regulatory submissions and timelines.
• Set standards for submission quality and cross-functional delivery.
• Build and develop a high-performing CMC Regulatory team.
• Oversee submission planning and ensure dossiers meet ICH and country requirements.
• Interpret data in cross-functional discussions and with health authorities.
• Advise executive leadership on regulatory expectations and strategy impact.
• Lead risk assessments and contingency planning within the CMC team.
• Establish relationships with CDMOs, health authorities, and executives.
• Determine resourcing, budget, and external vendor use for CMC Regulatory.

Skills

Regulatory leadership

CMC regulatory strategy

FDA/EMA submissions

Cross-functional leadership

Biopharmaceutical expertise

Regulatory program management

Education

BS in Biochemistry/Biology/Chemistry/Engineering

Advanced degree preferred

Job description

Kailera Therapeutics in the United States is seeking a Vice President of CMC Regulatory to lead all aspects of CMC regulatory strategy at a pivotal Phase 3 planning stage. The role reports to the Senior VP of Regulatory and requires extensive drug development expertise and a track record with FDA/EMA submissions.

The successful candidate will build and lead a high-performing CMC team, manage global submissions, and partner with QA/Manufacturing to ensure regulatory readiness for launch while