Director, Regulatory CMC

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.

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 manufacturing and quality changes.

•Lead interactions and communications with regulatory agencies regarding CMC topics, e.g., pre-IND, end-of-phase, and pre-submission meetings.

•Work with a sense of purpose to get work done using influence and good project management skills, fostering alignment with organizational goals.

•Collaborate with Quality, CMC, R&D, Finance, Legal, Clinical, and other internal departments to ensure regulatory compliance and readiness; partner effectively with CROs and consultants.

Education

•Bachelor's degree in Chemistry, Pharmacy, Life Sciences, or a related field required; advanced degree (PhD, PharmD, MS) highly preferred.

•Minimum of 10+ years of experience in CMC regulatory affairs within the biopharmaceutical or pharmaceutical industry, including experience with small molecule development in oncology; more experience is a plus.

•Proven track record of successful CMC submissions and approvals in the US and internationally.

•In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC.

•Strong leadership, communication, and project management skills.

•Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble.

•Ability to work effectively in a collaborative, fast-paced environment.

• The opportunity to build and lead a critical function at a pivotal inflection point in Immuneering's clinical journey.
• A collaborative, science-first culture that values expertise, initiative, and patient impact.
• Competitive compensation, equity participation, and exceptional benefits.
• Fully remote work environment with a flexible, results-oriented culture.

Immuneering Corporation is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Originally posted on Himalayas