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Regulatory Affairs CMC Associate Director

Contract Type: Permanent
Location: Dublin
Contact Name: Gerry Kennedy
Contact Email: gerry@rftgroup.ie

Job Description

Regulatory Affairs Global CMC, Associate Director - Dublin Pharma

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.

Job Spec
  • 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.
Person Spec
  • 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 gerry@rftgroup.ie 01 2302400 www.rftgroup.ie