Regulatory Affairs Manager
Kilkenny

Permanent
​€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: 
  • 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.