Associate Director / Director, Regulatory Affairs CMC
Immunome, Inc.
August 29, 2026
Remote friendly (Bothell, WA)
United States
Corporate Functions
Position Overview
Associate Director / Director, Regulatory Affairs CMC responsible for developing and executing global regulatory CMC strategies across multiple modalities; managing key deliverables and ensuring adherence to accelerated regulatory submission schedules. Leads communications/interactions with global regulatory authorities and collaborates cross-functionally with Technical Operations, Quality Assurance, Supply Chain Management, and Project Management.
Responsibilities
- Develop and execute global regulatory CMC strategies across clinical and commercial stages.
- Serve as regulatory CMC lead on cross-functional teams, providing strategic input to technical operations, supply chain, quality, and project teams.
- Author, review, and manage preparation of high-quality CMC sections for regulatory submissions (IND, CTAs, IMPD, annual reports, pediatric plans, amendments, marketing applications).
- Lead interactions with global health authorities on CMC topics (briefing packages, responses to information requests, meeting representation).
- Collaborate with internal and external stakeholders to ensure regulatory compliance and alignment with regulatory CMC strategies.
- Maintain current knowledge of regulations and guidelines (ICH, FDA, EMA) and global regulatory changes.
- Support regulatory inspections as required.
Qualifications
- Bachelor’s degree in a relevant scientific discipline required; advanced degree a plus.
- 7+ years pharmaceutical/biotech industry experience; 5+ years regulatory CMC (or equivalent).
- Hands-on experience preparing CMC submissions for small molecules, biologics, and/or antibody-drug conjugates.
- Experience with regulatory CMC strategy development and health authority interactions.
Knowledge and Skills
- Deep understanding of ICH, FDA, and EMA guidelines.
- Outstanding communication, analytical, organizational, and time-management skills.
- Strong written/verbal communication with attention to detail.
- Ability to lead cross-functional teams.
- Flexible, pragmatic approach to changing priorities.
- Proficiency with submission management software (e.g., Veeva RIM).
Associate Director / Director, Regulatory Affairs CMC responsible for developing and executing global regulatory CMC strategies across multiple modalities; managing key deliverables and ensuring adherence to accelerated regulatory submission schedules. Leads communications/interactions with global regulatory authorities and collaborates cross-functionally with Technical Operations, Quality Assurance, Supply Chain Management, and Project Management.
Responsibilities
- Develop and execute global regulatory CMC strategies across clinical and commercial stages.
- Serve as regulatory CMC lead on cross-functional teams, providing strategic input to technical operations, supply chain, quality, and project teams.
- Author, review, and manage preparation of high-quality CMC sections for regulatory submissions (IND, CTAs, IMPD, annual reports, pediatric plans, amendments, marketing applications).
- Lead interactions with global health authorities on CMC topics (briefing packages, responses to information requests, meeting representation).
- Collaborate with internal and external stakeholders to ensure regulatory compliance and alignment with regulatory CMC strategies.
- Maintain current knowledge of regulations and guidelines (ICH, FDA, EMA) and global regulatory changes.
- Support regulatory inspections as required.
Qualifications
- Bachelor’s degree in a relevant scientific discipline required; advanced degree a plus.
- 7+ years pharmaceutical/biotech industry experience; 5+ years regulatory CMC (or equivalent).
- Hands-on experience preparing CMC submissions for small molecules, biologics, and/or antibody-drug conjugates.
- Experience with regulatory CMC strategy development and health authority interactions.
Knowledge and Skills
- Deep understanding of ICH, FDA, and EMA guidelines.
- Outstanding communication, analytical, organizational, and time-management skills.
- Strong written/verbal communication with attention to detail.
- Ability to lead cross-functional teams.
- Flexible, pragmatic approach to changing priorities.
- Proficiency with submission management software (e.g., Veeva RIM).