Regulatory Affairs Manager
Our client, a multinational medical device and healthcare company, is seeking a Regulatory Affairs Manager.
This position focuses on implementing and controlling policy and strategy rather than developing it. The successful candidate will typically handle short-term operational/tactical responsibilities.
The ideal candidate will have experience in developing projects or sites from scratch.
Key Responsibilities:
* Oversee the implementation and operation of strategies for directing product registration submission, progress reports, supplements, amendments, or periodic experience reports.
* Interact with regulatory agencies to expedite approval of pending registration.
* Serve as regulatory liaison throughout the product lifecycle.
* Participate in 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:
* Manufacturing operations and manufacturing change experience.
* People management experience.
* Experience resolving nonconformance issues.
* Strong attention to detail.
* Solid communication skills and ability to communicate at all levels.
* Experience with EU and US regulatory bodies.
* Strong organizational skills.
Desirable Skills:
* Ability to adapt to change.
* Capacity to maintain clear and concise communication with governing bodies.
* Experience reviewing manufacturing changes.
* Optimization of regulatory acceptance changes.
* Supporting manufacturing operations.
* Dealing with ad-hoc issues.
* Capability to work under tight deadlines.
Qualifications:
* Minimum Level 8 Degree in Engineering or Science or related discipline.
* Minimum of 5 years of experience in a similar position and experience with EU Regulatory bodies in regards to applications and submissions or equivalent international experience.