Regulatory Affairs Specialist

Salary
Negotiable
Posted
07 Feb 2018
Closes
09 Apr 2018
Ref
Reg Specialist 21

Core Responsibilities

  • Leading Regulatory affairs projects related to module 3 of Dossiers
  • Be able to deal with other products which are
  • Experience of GMP and Quality systems

Responsibilities

  • Generation and compilation of data and product dossiers in accordance with European and other country specific regulations
  • Organisation of database and application of registration
  • Renewal and variation where appropriate
  • Preparation and maintenance of product labelling
  • Can work independently
  • Can use own initiative within a small team
  • Has experience of liaising with country-specific distributors and regulatory bodies
  • You will also be expected to mentor more junior colleagues.  

Experience

  • Experience 4 years Regulatory Affairs is essential
  • Involvement in contract development and manufacturing
  • Experience in R&D

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