The Associate Director position, Regulatory Affairs Global CMC will be responsible for managing and leading registration and CMC regulatory support for commercial and development projects worldwide.
- Activities, including planning, writing and reviewing Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). Manage the internal review and submission of these items.
- Participate as an active member of a multi-disciplinary team to establish development and Regulatory CMC strategies for commercial products, late, and early stage development programs. Identify and communicate potential risks associated with strategy scenarios.
- Manage EU, US commercial license maintenance.
- Provide in-depth reviews of protocols, reports, presentations, and documents.
- Manage CMC related regulatory agency interactions.
- Ideally candidates will have an advanced degree in a relevant science discipline.
- Must have at least 10+ years of pharmaceutical industry experience and 7+ years in Regulatory CMC.
Solid working knowledge of CMC regulatory and ability to generate clear, well-argued positions.
Knowledge of FDA, EMA and ICH guidelines
- Must have experience with CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs)
- Strong English language - written and verbal communication skills.
- Demonstrated understanding and strategic application of regulations and guidelines for drug development.
- Solid understanding of and experience with electronic Common Technical Document eCTD submissions.
Cv to email@example.com 01 2302400 www.rftgroup.ie