Director, Global Regulatory CMC

Job Summary
The Director, Global Regulatory CMC will provide strategic and operational regulatory CMC support for BioCryst development programs, developing and implementing a Global Regulatory CMC plan and coordinating regulatory CMC activities with Clinical, Nonclinical, Regulatory, and QA groups.

Essential Duties & Responsibilities
- Manage all global regulatory activities, providing leadership and consultation for global regulatory CMC from early development through approval.
- Develop regulatory CMC strategy and prepare CMC submissions to FDA, EMA, PMDA, Health Canada, and other health authorities.
- Manage and prepare CMC regulatory submission documents for assigned projects, including INDs, CTAs, IMPDs, BLAs/NDAs, MAAs, and JNDAs.
- Provide strategic regulatory input for manufacturing site transfers.
- Determine submission contents for product changes from manufacturing facilities.
- Review and approve specifications, stability protocols, product change notices, and related documents.
- Provide day-to-day regulatory advice to product development and quality assurance.
- Manage regulatory CMC timelines and advise program leads/senior leadership of risks to timelines or potential regulatory issues.
- Maintain working relationships with internal and cross-company teams as primary CMC liaison.
- Maintain currency with FDA regulations and guidance (including INDs and BLAs/NDAs) and be familiar with Ex-US regulations (e.g., EMA, PMDA).

Experience & Qualifications
- Bachelor’s degree in a scientific discipline required; MS/PhD desired.
- Minimum 10 years’ regulatory CMC experience (or equivalent combination of education/experience).
- Experience authoring CMC portions of IND and BLA filings; experience with drug/device combination products.
- Experience participating in regulatory agency meetings (CMC portions of meeting requests and briefing documents).
- Ability to develop and maintain positive relationships with regulatory authorities.
- Ability to multi-task and quickly adapt to change.
- Working knowledge of FDA, EU, and ICH CMC regulations/guidances (international experience a plus).
- Knowledge of small/large molecule manufacturing, validation, and analytical methods.
- Knowledge of Health Authority CMC regulations/guidance for investigational products and marketing application preparation/submission.
- Strong leadership and interpersonal skills.
- Excellent English written/verbal communication and technical writing/editorial and presentation skills.
- Computer literate (MS Word, MS PowerPoint, MS Excel).