Key Duties;
1. Oversee the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
2. Interact with regulatory agency to expedite approval of pending registration.
3. Serve as regulatory liaison throughout product lifecycle.
4. Participate in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
5. Ensure timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
6. Serve as regulatory representative to marketing, research teams and regulatory agencies.
7. Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
Requirements
8. Level 8 Degree in Engineering or Science or related discipline.
9. Min 5 years of experience in a similar position and experience with EU Regulatory bodies in regards to applications and submissions or equivalent international experience.
10. Manufacturing operations and manufacturing change experience.
11. People management experience.
12. Experience resolving any issues regarding non-conformance.
13. Strong attention to detail.
14. Solid communication skills and ability to communicate at all levels.
15. Experience with EU and US regulatory bodies.
16. Strong organisational skills.
For more information please contact Clodagh D'Arcy on or email details to