Associate Director, Regulatory CMC

About this opportunity :

The Associate Director, Regulatory CMC leads CMC regulatory activities in a CDMO environment, with primary ownership of CTD Module 3 (Drug Substance) authoring and platform Drug Master Files (DMFs) supporting multiple external clients. This role serves as the primary Regulatory CMC interface for clients, internal technical teams, and health authorities, ensuring high‑quality, compliant regulatory deliverables across diverse programs. The Associate Director partners closely with Process Development, Analytical Development, Manufacturing, Quality, and external writers/consultants to translate CDMO processes and data into regulator‑ready submissions and responses.

Key Responsibilities

• Provide Regulatory CMC leadership for CDMO services across multiple clients, development stages, and regulatory pathways.
• Advise clients on CMC regulatory strategy related to CDMO platforms, processes, controls, and change management.
• Act as a trusted regulatory partner, clearly communicating risks, options, and implications of CDMO‑driven changes.
• Lead planning, authoring, review, and compilation of CTD Module 3 Drug Substance sections (S.1–S.7).
• Ensure alignment with ICH M4Q, ICH Q7–Q11, and applicable global requirements (FDA, EMA, Health Canada, PMDA, NMPA).
• Coordinate inputs from internal SMEs (PD, AD, Manufacturing, Engineering, QC, QA) and external writers/consultants.
• Ensure traceability to source documents, reports, and GMP records; oversee document control and versioning.
• Own authoring, submission, and maintenance of platform DMFs representing CDMO processes or excipients.
• Manage DMF lifecycle activities including amendments, annual reports, LOAs, and global equivalents.
• Serve as primary CMC regulatory contact for health authority communications related to DMFs and client submissions.
• Lead authoring and coordination of health authority responses and support client regulatory meetings.
• Lead or support regulatory impact assessments for changes to materials, suppliers, processes, methods, specifications, and stability programs.
• Classify changes, define regulatory pathways, and translate impacts into clear client guidance aligned with ICH Q12.
• Support regulatory inspections and review regulatory aspects of deviations, CAPAs, OOS/OOTs, and specification changes.
• Develop CMC regulatory templates, authoring standards, training, and best‑practice dossiers for CDMO services.
• Monitor evolving global CMC regulatory requirements and translate updates into internal processes and client communications.

Required Skills/Abilities

• Bachelor’s degree in a scientific discipline; advanced degree strongly preferred.
• 10 years of industry experience, including 7 years in Regulatory CMC.
• Hands‑on expertise with CTD Module 3 Drug Substance authoring and DMF lifecycle management.
• Experience interacting with global health authorities.
• Strong knowledge of cGMP, global CMC regulations, and regulatory change management.
• Excellent technical writing, project management, and cross‑functional collaboration skills.
• Ability to manage competing priorities in a fast‑paced, client‑driven environment.
• Ability to travel approximately 10–20%.

The annualized salary range for this position is between $165,200.00 - $202,000.00.