Global CMC Regulatory Affairs Director (Assoc/Dir)

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

Job summary

Immunome, Inc. seeks an Associate Director / Director, Regulatory Affairs CMC to lead global regulatory CMC strategies across modalities. You will manage key deliverables and ensure alignment with accelerated submission timetables, while communicating with global health authorities.

This role reports to the Senior Director, Regulatory Affairs CMC and partners with Technical Operations, QA, Supply Chain, and Project Management to ensure regulatory compliance and timely filings.

Qualifications

• Bachelor’s degree in a scientific field; advanced degree a plus.
• 7+ years in pharma/biotech with 5+ years in regulatory CMC.
• Hands-on experience preparing CMC submissions for small molecules, biologics, or ADCs.

Responsibilities

• Develop and execute global regulatory CMC strategies for clinical and commercial programs.
• Lead CMC activities on cross-functional teams including ops, QA, supply chain and project management.
• Author and manage CMC sections for INDs, CTAs, IMPD, annual reports and amendments.

Skills

Regulatory CMC knowledge

Cross-functional leadership

Regulatory strategy

Excellent written/verbal communication

Submission management (Veeva RIM)

Education

Bachelor’s degree in a relevant scientific discipline

Advanced degree (MS/PhD) preferred

Tools

Veeva RIM

Job description

Immunome, Inc. seeks an Associate Director / Director, Regulatory Affairs CMC to lead global regulatory CMC strategies across modalities. You will manage key deliverables and ensure alignment with accelerated submission timetables, while communicating with global health authorities.

This role reports to the Senior Director, Regulatory Affairs CMC and partners with Technical Operations, QA, Supply Chain, and Project Management to ensure regulatory compliance and timely filings.