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Regulatory Affairs Manager Europe

4 maanden geleden

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At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

Abbott Diabetes Care's leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre systems.

THIS IS HOW YOU CAN MAKE A DIFFERENCE AT ABBOTT:

Reporting to the Regulatory Affairs Director for Europe, Middle East and Africa, the Regulatory Affairs Manager, Europe will focus is on managing a small regulatory manufacturing organization and ensuring fruitful regulatory process throughout product lifecycle.

It would be advantageous if you could bring experience in developing projects or sites from square one.

As the Regulatory Affairs Manager, 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.

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.

Strong organisational skills.

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.

Abbott is an equal opportunities employer.

This role can be based in one of our Abbott offices in Ireland, the United Kingdom, Germany, France, or the Netherlands.