In this role you will be in charge of managing teams within the Regulatory Affairs Sub-Function.
Focus is on policy and strategy implementation and control rather than development and you will typically handle short-term operational/tactical responsibilities.
As the Manager of the Regulatory Affairs Sub-Function, you will be responsible to:
* 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.
For this position it will be necessary to bring:
* 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 organisational skills.
You should also have:
* 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.
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