Regulatory Affairs Manager
This position is within a multinational medical device and health care company. The Regulatory Affairs Manager will oversee the teams within the Regulatory Affairs Sub-Function.
The core focus of this role is on policy and strategy implementation and control rather than development, handling short-term operational/tactical responsibilities.
The ideal candidate will bring experience in developing projects or sites from scratch.
Main Responsibilities:
* Oversee strategy implementation and operations for directing product registration submission, progress reports, supplements, amendments, or periodic experience reports.
* Interact with regulatory agencies to expedite approval of pending registration.
* Act as a 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.
* Represent regulatory affairs 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.
* Ability to resolve 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.
Nice-to-Have Skills:
* Ability to adapt to change.
* Capacity to keep external communication clear and concise with governing 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 & 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.