Regulatory Affairs Manager
Kilkenny
Permanent
€92k
€92k
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:
For this position it will be necessary to bring:
You should also have:
QUALIFICATIONS AND EXPERIENCE
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.