Director, Regulatory Affairs CMC
Overview
An established pharmaceutical organization is seeking a Director of Regulatory Affairs CMC Strategy to lead global regulatory planning and execution related to Chemistry, Manufacturing, and Controls (CMC). This role supports products from early development through post‑approval lifecycle management and serves as a key partner to CMC, Quality, and R&D teams. The director will also lead interactions with global health authorities and provide strategic regulatory guidance across the organization.
Responsibilities
- Develop and implement global CMC regulatory strategies across all stages of development and commercialization.
- Lead the preparation, review, and submission of CMC components for major filings, including INDs/CTAs, NDAs/BLAs/MAAs, and post‑approval supplements.
- Serve as the primary liaison for CMC discussions with global health authorities; lead meetings and address information requests and deficiency letters.
- Collaborate closely with Quality, CMC Operations, R&D, and Clinical Supply to ensure compliance with cGMP and evaluate regulatory impacts of manufacturing and development changes.
- Monitor changes in global regulatory guidelines (e.g., ICH) and communicate impacts to senior leadership.
- Provide leadership, mentorship, and guidance to regulatory team members and contribute to project prioritization.
Qualifications
- Bachelor's degree in a scientific discipline (Chemistry, Pharmacy, Biology, Engineering) required; advanced degree (MS, PhD, PharmD) preferred.
- 10-15+ years of pharmaceutical industry experience, with 8-10+ years focused specifically on CMC Regulatory Affairs.
- Strong knowledge of eCTD formats and global CMC regulatory requirements (U.S., EU, Canada).
- Proven track record supporting major regulatory submissions and marketing application approvals.
- Ability to lead negotiations, manage conflict, and influence cross‑functional teams.
- Experience with multiple small‑molecule dosage forms preferred; biologics experience is a plus.
- Familiarity with Veeva Vault systems.
- Willingness to travel up to 20% domestically and internationally.
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