Vice President, CMC Regulatory Affairs

The role

The Vice President of CMC Regulatory will lead all aspects of CMC Regulatory and provide strategic and operational leadership to the CMC Regulatory and integrated CMC teams. The role involves planning for Phase 3 and developing global CMC regulatory strategy for the portfolio.

What you will do

• Develop and own the global CMC regulatory strategy for the portfolio
• Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities
• Ensure the appropriate execution of CMC regulatory strategy
• Set standards and expectations for submission quality and cross-functional delivery
• Build, lead, and develop a high-performing CMC Regulatory team
• Oversee all CMC-related submission planning and execution
• Interpret and discuss data within cross-functional teams and with health authorities
• Advise executive leadership on evolving global regulatory expectations and industry trends
• Lead the preparation of risk assessments on CMC regulatory topics
• Establish and lead strategic relationships with CDMO partners, health authorities, and internal executives

Required qualifications

• 15+ years of biopharmaceutical industry experience
• 10+ years of relevant Regulatory CMC
• Demonstrated track record of successful submissions to FDA and/or other health authorities, including EMA
• Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
• Ability to motivate and lead others, both with direct line and within integrated team
• Excellent interpersonal, verbal and written communication skills
• Ability to effectively lead and influence others
• Comfortable in a fast-paced small company environment with minimal direction
• BS degree in Biochemistry, Biology, Chemistry, Engineering or related field

Nice to have

• advanced degree

Benefits

• comprehensive health coverage
• flexible time off
• paid holidays
• year-end shutdown
• monthly wellness stipend
• generous 401(k) match
• tuition reimbursement
• commuter benefits
• disability and life insurance
• annual bonus opportunities
• equity grants

Before you apply

• Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires

About the company

Kailera is working to advance novel therapies for obesity and related conditions. The company is rooted in an entrepreneurial spirit and a team-oriented culture.