Regulatory Affairs Manager
We are seeking a highly skilled Regulatory Affairs Manager to join our team at a multinational medical device and health care company. This role will involve managing teams within the Regulatory Affairs Sub-Function, with a focus on policy and strategy implementation and control.
The successful candidate will be responsible for overseeing the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Key responsibilities include:
* Interacting with regulatory agencies to expedite approval of pending registration.
* Serving as 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 regulatory representative to marketing, research teams, and regulatory agencies.
Requirements for this position include:
* Manufacturing operations and manufacturing change experience.
* People management experience.
* Experience resolving any issues regarding nonconformance.
* 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 and experience include:
* Ability to adapt to change.
* Capacity to keep external communication to governing bodies clear and concise, avoiding any confusion with regulatory bodies.
* Experience reviewing manufacturing changes.
* Optimization of regulatory acceptance changes.
* Supporting manufacturing operations.
* Dealing with Ad Hoc Issues.
* Capability to work with tight deadlines.
Qualifications and experience:
* 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.
Salary: Estimated $120,000 - $150,000 per year based on location and industry standards.