Director, Regulatory CMC

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

Technical / Soft Skills

•    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 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.