Vice President, CMC Regulatory Affairs

Title: Vice President, CMC Regulatory Affairs Location: US-Remote

What You’ll Do:

Vice President of CMC Regulatory will lead all aspects of CMC Regulatory. Reporting into the Senior Vice President of Regulatory, you will provide strategic and operational leadership to ensure the effectiveness of the CMC Regulatory team and the integrated CMC team. With their lead candidate planning to initiate Phase 3, the candidate must plan for and have extensive drug development expertise. The company offers innovative science, competitive compensation, and a patient-focused company culture.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

Responsibilities:

• 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 (e.g., End-of-Phase 2, pre-submission, Scientific Advice) 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. This includes organizational design, hiring, succession planning, and coaching managers to grow as leaders
• Oversee all CMC-related submission planning and execution, ensuring that high quality and accurate submission documents are completed within target timelines
• 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. Predict potential regulatory questions and develop robust contingency and mitigation plans with the integrated CMC team
• Establish and lead strategic relationships with CDMO partners, health authorities, and internal executives, and break down silos to enable integrated CMC execution
• Ensure CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries
• Determine resourcing, budget, and use of external consultants and vendors for CMC Regulatory, and influence resource allocation across the integrated CMC organization (Process Development, Manufacturing, Analytical, Quality)
• Partner with Quality and Technical Operations on commercial manufacturing readiness, process validation, comparability, and pre-approval inspection strategy. Define the post-approval change and lifecycle management strategy

Required Qualifications:

• 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

Education:

• BS degree in Biochemistry, Biology, Chemistry, Engineering or related field required; advanced degree preferred