Director, Regulatory CMC

ABOUT IMMUNEERING

Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic Inhibition platform. Our lead asset, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK in active Phase 2 and Phase 3 (MAPKeeper 301) clinical trials in pancreatic cancer and RAS-mutant non-small cell lung cancer, as well as additional solid tumor programs. We are committed to delivering transformative treatments to patients with limited options through rigorous science and a collaborative, mission-driven culture.

Primary Responsibilities

The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing, and Controls) is a pivotal regulatory role responsible for developing and executing regulatory strategies for CMC activities across the company's clinical product portfolio. This position ensures compliance with all applicable regulatory requirements and works cross-functionally to support product development, registration, and lifecycle management. A successful candidate will be a highly collaborative individual with strong interpersonal skills and an exceptional team player with the ability to lead Regulatory CMC.

• Develop and lead global CMC regulatory strategies for investigational and commercial products to ensure timely submissions and approvals.
• Prepare, review, and submit CMC sections of regulatory documents including INDs, IMPDs, NDAs, BLAs, ANDAs, and supplements to FDA and other regulatory authorities including the EMA.
• Provide regulatory guidance on CMC matters to project teams, including manufacturing changes, process development, and technology transfers.
• Monitor and interpret current and emerging CMC regulatory requirements, guidelines, and trends to proactively address potential impacts.
• Represent Regulatory CMC in cross-functional teams and meetings, providing expertise and input on regulatory implications of