- 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.
- 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.
- 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.
- 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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Regulatory Affairs Manager - Kilkenny, Ireland - Abbott
Description
Have you ever wanted to make a difference?
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 Ireland
In Ireland, Abbott employs over 5,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
Diabetes Care Kilkenny
Abbott Diabetes Care is opening a new site, in Kilkenny, that will be at the forefront of Diabetes care with the latest technology, to manufacture FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre systems.
This is how you can make a difference at Abbott:
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.
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:
For this position it will be necessary to bring:
You should also have:
QUALIFICATIONS AND EXPERIENCE
Abbott is an equal opportunities employer.
