VP, CMC Regulatory Affairs — Remote/Hybrid Leader

Kailera Therapeutics; Waltham (MA); Hybrid; USD 272.000 - 340.000; Vollzeit

Zusammenfassung

Kailera Therapeutics seeks a Vice President of CMC Regulatory to lead global CMC regulatory strategy and execution as Phase 3 advances. The role requires directing interactions with FDA, EMA, and other authorities and building a high-performing team in a fast-paced biotech environment.

Hybrid work options are available with hub-based onsite requirements in MA; the position emphasizes strategic planning, risk management, and cross-functional collaboration to support launch readiness and lifecycle

Qualifikationen

• 15+ years of biopharmaceutical industry experience; with 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 as well as the ability to effectively lead and influence others.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

Aufgaben

• Develop and own the global CMC regulatory strategy for the portfolio, and provide input to corporate and program strategy, including Phase 3 readiness, marketing application planning, and launch.
• Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities, including leading CMC-focused meetings and responses to information requests.
• Responsible for ensuring the appropriate execution of CMC regulatory strategy.
• Set standards and expectations for submission quality and cross-functional delivery and hold the team accountable for results.
• Build, lead, and develop a high-performing CMC Regulatory team as the company scales toward registration.
• Oversee all CMC-related submission planning and execution, ensuring high quality and accurate submission documents.
• Accurately interpret and discuss data within cross-functional teams and with health authorities.
• Anticipate evolving global regulatory expectations and industry trends, advise executive leadership on their impact, and adjust CMC regulatory strategy accordingly.
• Lead the preparation of risk assessments on CMC regulatory topics and develop contingency plans with the integrated CMC team.
• Establish and lead strategic relationships with CDMO partners, health authorities, and internal executives to enable integrated CMC execution.
• Ensure CMC dossiers meet ICH format and country-specific requirements.
• Determine resourcing, budget, and use of external consultants and vendors for CMC Regulatory.
• Partner with Quality and Technical Operations on manufacturing readiness, process validation, and lifecycle management.

Kenntnisse

Regulatory CMC leadership

FDA/EMA submissions

Cross-functional leadership

Strategic planning

Stakeholder management

Ausbildung

BS degree in Biochemistry/Biology/Chemistry/Engineering

Jobbeschreibung

Kailera Therapeutics seeks a Vice President of CMC Regulatory to lead global CMC regulatory strategy and execution as Phase 3 advances. The role requires directing interactions with FDA, EMA, and other authorities and building a high-performing team in a fast-paced biotech environment.

Hybrid work options are available with hub-based onsite requirements in MA; the position emphasizes strategic planning, risk management, and cross-functional collaboration to support launch readiness and lifecycle