Director, Global Regulatory CMC
A global biopharmaceutical company is seeking an experienced Director, Global Regulatory CMC to lead regulatory CMC strategy and execution across multiple development programs. This role will partner closely with cross‑functional teams to drive global regulatory submissions and ensure alignment of CMC strategy with clinical, nonclinical, quality, and technical operations.
Key Responsibilities
- Lead all global regulatory CMC activities from early development through approval.
- Develop and implement CMC regulatory strategy for submissions to FDA, EMA, PMDA, Health Canada, and other global authorities.
- Oversee preparation, review, and delivery of regulatory CMC documentation for INDs, CTAs, IMPDs, BLAs/NDAs, MAAs, JNDAs, and related filings.
- Provide regulatory guidance for manufacturing site transfers and product lifecycle changes.
- Review and approve specifications, stability protocols, change controls, and related CMC documents.
- Serve as the primary CMC regulatory liaison to internal teams, ensuring alignment and efficient communication.
- Manage timelines, identify risks, and ensure regulatory milestones are met.
- Stay current with global regulatory requirements and evolving CMC guidelines.
Qualifications
- Bachelor's degree in a scientific discipline required; MS or PhD preferred.
- Minimum of 10 years of regulatory CMC experience in pharmaceuticals or biotechnology.
- Proven experience authoring CMC sections of INDs and BLAs; experience with drug‑device combination products preferred.
- Experience preparing CMC content for regulatory agency meetings.
- Strong understanding of FDA, EU, ICH, and global CMC regulations and guidance.
- Knowledge of small‑ and large‑molecule manufacturing, validation, and analytical methods.
- Strong leadership, communication, and cross‑functional collaboration skills.
- Proficiency in Microsoft Office suite.
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