Associate Director / Director, Regulatory Affairs CMC

Develop and execute global regulatory CMC strategies across clinical and commercial stages. Serve as the regulatory CMC lead on cross-functional teams, providing strategic input to technical operations, supply chain, quality, and project teams. Author, review, and manage the preparation of high-quality CMC sections for regulatory submissions including INDs, CTAs, IMPDs, annual reports, pediatric plans, amendments, and marketing applications. Lead interactions with global health authorities on CMC topics, including preparation of briefing packages, responses to information requests, and representation at meetings. Collaborate with internal and external stakeholders to ensure regulatory compliance and alignment with regulatory CMC strategies while maintaining current knowledge of ICH, FDA, and EMA guidelines. Support regulatory inspections as required. This role reports to the Senior Director, Regulatory Affairs CMC at Immunome, a clinical-stage targeted oncology company advancing a portfolio of therapeutics including antibody-drug conjugates and solid tumor treatments.