Regulatory Affairs Manager
The Regulatory Affairs Manager will be in charge of managing teams within the Regulatory Affairs Sub-Function.
Key Responsibilities:
* Oversee strategy implementation and operations for directing development of 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, and chemistry manufacturing control (CMC).
* Ensure timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
* 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.
Preferred Skills:
* Ability to adapt to change.
* Capacity to keep external communication clear and concise.
* 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.