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Regulatory Affairs Consultant

Essex
Competitive
16-08-2019
23343

This vacancy has now expired

One of Quanta’s pharmaceutical clients based in the South East of the UK is looking for a Regulatory Affairs Consultant to join their team on a 6-month contract basis.

The successful candidate will be responsible for supporting the Senior Regulator Affairs Officer with a variety of regulatory activities listed below.

Role:
  • Support submissions of initial marketing authorisation applications and variations
  • Creating, updating and reviewing labelling, package leaflets and summary of product characteristics, ensuring compliance with current legislation and registered particulars
  • Compiling responses to enquiries and deficiencies from regulatory bodies
  • Creation and maintenance of product registration files
  • Provide regulatory advice and guidance, when required
  • Carry out administrative activities where necessary to ensure the effective operation of the department
  • Support with quality and compliance related matters
Requirements:
  • BSc. or MSc. In Pharmacy, Chemistry or related science
  • Ability to communicate effectively with internal functions and external partners
  • 2 years+ experience in local Regulatory Affairs/ dossier registration, preferably within generics
  • Good knowledge of post-marketing authorisation maintenance including variations (Type IA/Type IB/Type II and PIQ notification/full applications) and renewals
  • Experience of liaising with the MHRA PIQ Unit is desirable
  • Working knowledge of regulatory database management is desirable
  • Candidates should be willing and able to travel as necessary
Apply today if this sounds like the position for you!




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