Vice President, CMC Regulatory Affairs

US-Remote · USD 272,000-340,000 · 10+ years experience · Remote · Posted Oct 19, 2026

At a glance

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.
The candidate must plan for and have extensive drug development expertise as the lead candidate plans to initiate Phase 3.

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 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 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

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
BS degree in Biochemistry, Biology, Chemistry, Engineering or related field required

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)