Global Regulatory CMC Director - Submissions & Strategy

Immunomeinc; Bothell (WA); On-site; USD 177,000 - 239,000; Full time

Job summary

Immunome, Inc. in Bothell, WA is seeking an Associate Director / Director, Regulatory Affairs CMC to lead global regulatory CMC strategies across modalities.

You will manage key deliverables and coordinate with Technical Operations, Quality Assurance, Supply Chain, and Project Management to align with regulatory expectations. This role requires a strong track record in regulatory CMC submissions (IND, CTAs, IMPD) and ongoing health authority interactions, with a focus on timely filings and

Qualifications

• Bachelor’s degree in a relevant scientific discipline required.
• Advanced degree a plus.
• 7+ years of pharmaceutical/biotechnology experience including 5+ years in regulatory CMC.
• Hands-on experience with CMC submission preparation for small molecules, biologics, and/or antibody-drug conjugates.

Responsibilities

• Develop and execute global regulatory CMC strategies across modalities.
• Lead cross-functional teams and provide strategic input to operations, QA, supply chain, and project teams.
• Author, review and manage CMC submission sections (IND, CTAs, IMPD, annual reports).
• Lead interactions with global health authorities and prepare briefing packages.

Skills

Regulatory CMC

CMC submissions

Health authority interactions

Cross-functional leadership

Communication skills

Attention to detail

Education

Bachelor’s degree in a relevant scientific discipline

Advanced degree is a plus

Job description

Immunome, Inc. in Bothell, WA is seeking an Associate Director / Director, Regulatory Affairs CMC to lead global regulatory CMC strategies across modalities.

You will manage key deliverables and coordinate with Technical Operations, Quality Assurance, Supply Chain, and Project Management to align with regulatory expectations. This role requires a strong track record in regulatory CMC submissions (IND, CTAs, IMPD) and ongoing health authority interactions, with a focus on timely filings and