Harty Search & Selection has been exclusively retained to source suitably qualified and high calibre candidates for the postion on Director – CMC Regulatory Affairs.
The main purpose of the role is to work closely with formulations, QC and manufacturing operations in terms of providing expert advise regarding the EU “CMC” regulatory trends and legislation.
- Manage timelines in cooperation with project management, Operations, Clinical Development and Regulatory Affairs to ensure on-time regulatory submissions.
- Assist with the planning, scientific writing and review of IMPDs, CTAs, MAAs, annual reports, DSUR and amendments to ensure a high quality regulatory submission and approval.
- Ensure that all submissions are of highest regulatory standard and meet the expectations of EU regulatory bodies.
- Assist in tracking of CMC regulatory commitments for INDs/IMPDs, CTAs, and BLAs/MAAs.
- Assist in review of “Change Controls” by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and to ensure that CMC related changes are reported
- Participate as needed, in planning, organizing and managing the CMC component of regulatory authority meetings including national EU agencies, the EMA and the international agencies as required.
Education and Experience:
- 3rd level degree in a science related discipline and a minimum of 15 years pharmaceutical industry experience.
- 6+ years relevant Regulatory Affairs CMC experience in a “large molecule” biopharma facility is a definite advantage
- Thorough understanding of EU Regulatory arena, to include CMC guidelines
- Existing relationship with EU Regulatory authorities
- Very comfortable when engaging with Quality Control, formulations and Manufacturing operations regarding “change controls”.
- Demonstrated influencing and relationship management skills
For further information on this role, please contact Liam at Harty Search & Selection; Office – 061-414533