Associate Director, Regulatory Affairs CMC

Responsibilities

• Support the development and execution of global RegCMC strategies for small-molecule programs across stages of development, from IND through NDA/MAA readiness.
• Identify and work in collaboration with CMC Team to address regulatory risks.
• Monitor evolving global health authority expectations and guidance (FDA, EMA, ICH) and translate them into actionable strategy.
• Author and review all applicable Quality sections for global regulatory filings, including IND/IMPD, annual reports, and briefing documents.
• Support and coordinate responses to CMC information requests with accuracy and timeliness.
• Partner with Pharmaceutical Development, Manufacturing, Quality, and Program Management to provide regulatory input on control strategy, specifications, manufacturing changes, comparability, process validation, and lifecycle management.
• Affiliate with CDMO and external partners from a regulatory perspective, ensuring alignment with submission commitments.

Requirements

• Advanced degree (MS, PhD, PharmD) in chemistry, pharmaceutical sciences, chemical engineering, or a related discipline; a Bachelor's degree with directly relevant experience will be considered.
• 7+ years of combined Regulatory Affairs CMC and pharmaceutical industry experience.
• Experience contributing to global CMC regulatory strategy for small-molecule programs across one or more stages of development.
• Working familiarity with ICH guidelines and applicable FDA/EMA guidance.
• Experience supporting IND, NDA, or MAA regulatory submissions.
• Ability to work both independently and collaboratively, and to prioritize in a fast-paced biotech environment.
• Strong written and verbal communication skills.

Preferred Qualifications

• Experience supporting a program through later-stage development or the clinical-to-commercial transition.
• Exposure to both early- and late-stage pipeline assets within the same organization.