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Key Responsibilities
* 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.
* 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 or email details to.
Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.
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