Vice President, CMC Regulatory Affairs (Fully Remote)

Kailera Therapeutics; United States; A distancia; USD 272.000 - 340.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health coverage

Flexible time off

Descripción de la vacante

Kailera Therapeutics in the United States is seeking a Lead CMC Regulatory Affairs leader to shape global CMC strategy and readiness for late-stage programs. You will lead regulatory submissions with FDA/EMA and partner with cross-functional teams to ensure compliant, timely approvals.

The role requires a patient-focused, strategic leader who builds high-performing teams and aligns regulatory plans with program milestones and business goals in a fast-paced biopharma environment.

Formación

• 15+ years biopharma experience with 10+ years in Regulatory CMC.
• Proven track record of successful FDA and EMA submissions.
• Leads global CMC regulatory strategy and cross-functional collaboration.

Responsabilidades

• Develop and own global CMC regulatory strategy, including Phase 3 readiness.
• Serve as lead CMC voice with FDA, EMA, and other health authorities.
• Build, lead, and develop a high-performing CMC Regulatory team.

Conocimientos

Regulatory Leadership

CMC Regulatory

Strategic Leadership

Descripción del empleo

• Lead CMC Regulatory Affairs and provide strategic leadership.
• Report to SVP of Regulatory and shape global CMC strategy.

Key Responsibilities:

• Develop and own global CMC regulatory strategy, including Phase 3 readiness.
• Serve as lead CMC voice with FDA, EMA, and other health authorities.
• Build, lead, and develop a high-performing CMC Regulatory team.

Qualifications & Benefits:

• 15+ years biopharma experience with 10+ years in Regulatory CMC.
• Proven track record of successful FDA and EMA submissions.
• Salary range $272,000 - $340,000 USD with comprehensive health coverage and flexible time off.

Kailera Therapeutics

Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.