▷ 3 Days Left: Regulatory Affairs Manager

4 weeks ago

Portlaoise, Ireland Cpl Healthcare Full time

Regulatory Affairs Manager

My client, a multinational medical device and health care company, is looking to recruit a Regulatory Affairs Manager. The Regulatory Affairs Manager will be in charge of managing teams within the Regulatory Affairs Sub-Function. The core focus of this position is on policy and strategy implementation and control rather than development, and you will typically handle short-term operational/tactical responsibilities. It would be advantageous if you could bring experience in developing projects or sites from square one.

As the Manager of the Regulatory Affairs, you will be responsible to:

1. Oversee the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
2. Interact with regulatory agencies to expedite approval of pending registration.
3. Serve as regulatory liaison throughout the product lifecycle.
4. Participate in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
5. Ensure timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
6. Serve as regulatory representative to marketing, research teams, and regulatory agencies.
7. 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:

1. Manufacturing operations and manufacturing change experience.
2. People management experience.
3. Experience resolving any issues regarding nonconformance.
4. Strong attention to detail.
5. Solid communication skills and ability to communicate at all levels.
6. Experience with EU and US regulatory bodies.
7. Strong organizational skills.

You should also have:

1. Ability to adapt to change.
2. Capacity to keep external communication to governing bodies clear and concise, avoiding any confusion with regulatory bodies.
3. Experience reviewing manufacturing changes.
4. Optimization of regulatory acceptance changes.
5. Supporting manufacturing operations.
6. Dealing with Ad Hoc Issues.
7. Capability to work with tight deadlines.

Qualifications & experience:

1. Minimum Level 8 Degree in Engineering or Science or related discipline.
2. 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.

For more information, please email eanna.grealy@cpl.ie

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