Key Duties;
- Oversee the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
- Interact with regulatory agency to expedite approval of pending registration.
- Serve as regulatory liaison throughout product lifecycle.
- Participate in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
- Ensure timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
- Serve as regulatory representative to marketing, research teams and regulatory agencies.
- Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
Requirements
- Level 8 Degree in Engineering or Science or related discipline.
- 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.
- Manufacturing operations and manufacturing change experience.
- People management experience.
- Experience resolving any issues regarding non-conformance.
- Strong attention to detail.
- Solid communication skills and ability to communicate at all levels.
- Experience with EU and US regulatory bodies.
- Strong organisational skills.
For more information please contact Clodagh D'Arcy on 019476356 or email details to [email protected]
