Associate Director, Regulatory Affairs CMC (Small Molecule), Remote, US East Coast A profitable, growing global rare disease biopharma is looking for a hands-on regulatory CMC strategist to own CMC regulatory strategy across its small-molecule portfolio, from first-in-human to new marketing applications.
Why this role
Own the strategy, not the writing: a dedicated CMC writing team handles authoring
Two major programs: a first-in-human IND (2027) and a new formulation NDA (2028), plus post-approval support for approved global products
Real independence: you'll lead CMC regulatory decisions and FDA/EMA interactions
Fully remote on the East Coast, with quarterly visits to headquarters
What you'll do
Develop and lead global (US/EU) CMC regulatory strategy from Phase 1 through registration and post-approval
Write briefing books and lead preparation for FDA and EMA meetings
Direct and review CMC content for INDs, CTAs, IMPDs, NDAs, and MAAs, and responses to agency questions
Work with CDMO partners on data, tech transfer, and change assessments (all drug substance and drug product manufacturing is outsourced)
Partner with regional regulatory leads, technical operations, and quality
What you'll bring
7+ years in regulatory CMC and/or CMC technical roles, focusing on small molecules
Hands-on strategy experience from Phase 1 to 3, including an initial IND or CTA
Strong technical understanding, across both drug substance and drug product
US and EU regulatory experience, ROW preferred
A track record of navigating challenging CMC situations independently
Experience working with CDMOs
NDA/MAA experience is a plus