Regulatory Affairs Manager

Galway  ‐ Onsite
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Description

Regulatory Affairs Manager

Job Description

Due to their current expansion, an exciting opportunity has arisen for a Regulatory Affairs Manager to join a well recognised International Pharmaceutical company. You will be working on both submissions and lifecycle activities for assigned products within your portfolio.

Key Duties
  • Responsible for the implementation of registration strategy for a number of projects ensuring the regulatory approval of successful products.

  • Strong communication with global & regional teams when necessary.
  • Responsible for managing a team of reg affair consultants.
  • Act as the product owner for a number of licensed products within your portfolio.
  • Ensure product maintenance & lifecycle management in line with regulatory requirements.
  • Managing any outsourced vendors if necessary.


Skills & Experience
  • Degree in Life Sciences or equivalent & 5+ years regulatory affairs experience.
  • Prior proven experience with EU regulatory procedures (CP,DCP, MRP)
  • Strong planning & organisational skills as well as the ability to prioritise & manage projects.
  • Demonstrate analytical skills & the ability to think strategically.


This is a great & exciting opportunity with a large scale company. If you would like to hear more please call me direct on or alternatively email John Lennon direct.
Start date
08/2015
From
Real Staffing
Published at
25.08.2015
Project ID:
972335
Contract type
Freelance
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