Associate Director / Director, Regulatory Affairs CMC

Responsibilities:
- Develop and execute global regulatory CMC strategies across clinical and commercial stages.
- Serve as the regulatory CMC lead on cross-functional teams (Technical Operations, Supply Chain, Quality, Project Management), providing strategic input.
- Author, review, and manage preparation of high-quality CMC sections for regulatory submissions (e.g., IND, CTAs, IMPD, annual reports, pediatric plans, amendments, marketing applications).
- Lead interactions with global health authorities on CMC topics, including briefing packages, responses to information requests, and representation at meetings.
- Collaborate with internal and external stakeholders to ensure regulatory compliance and alignment with regulatory CMC strategies.
- Maintain current knowledge of regulations and guidelines (ICH, FDA, EMA) and track global regulatory changes.
- Support regulatory inspections, as required.

Qualifications:
- Bachelor’s degree in a relevant scientific discipline (advanced degree a plus).
- Minimum 7 years of pharmaceutical/biotechnology industry experience, including 5+ years in regulatory CMC (or equivalent).
- Hands-on experience preparing CMC submissions for small molecules, biologics, and/or antibody-drug conjugates.
- Experience with regulatory CMC strategy development and health authority interactions.

Knowledge & Skills:
- Deep understanding of ICH, FDA, and EMA guidelines.
- Strong communication, analytical, organizational, and time management skills.
- Ability to lead cross-functional teams.
- Flexible, pragmatic approach to changing priorities.
- Proficiency in submission management software (e.g., Veeva RIM).