Regulatory Affairs Manager
My client, a multinational medical device and health care company, is looking to recruit a Regulatory Affairs Manager. This position focuses on policy and strategy implementation and control rather than development.
You will oversee the strategy implementation and operations for directing product registration submission, progress reports, supplements, amendments, or periodic experience reports. You will also interact with regulatory agencies to expedite approval of pending registration.
The key responsibilities of this role include:
* Overseeing the strategy implementation and operations for directing product registration submission, progress reports, supplements, amendments, or periodic experience reports.
* Interacting with regulatory agencies to expedite approval of pending registration.
* Serving as a regulatory liaison throughout the product lifecycle.
* Participating in product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
* Ensuring timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
* Serving as a regulatory representative to marketing, research teams, and regulatory agencies.
* Advising development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
This position requires individuals with strong attention to detail, solid communication skills, and ability to communicate at all levels. Experience with EU and US regulatory bodies is also necessary.
Key qualifications include:
* A minimum Level 8 Degree in Engineering or Science or related discipline.
* A 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.
This role involves adapting to change, maintaining clear and concise external communication, reviewing manufacturing changes, optimizing regulatory acceptance changes, supporting manufacturing operations, and dealing with ad hoc issues. It requires capability to work with tight deadlines.