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Regulatory Affairs Officer

Regulatory Affairs Officer

Posted 6 April by Randstad Easy Apply Ended

Role : Regulatory Affairs Officer

Hours : 9-5

Pay : £28,000 - £37,000 depending on experience + benefits

Benefits : 25 days holiday, pension, life assurance and targeted bonus

Location :

BPL is based in Borehamwood, the enclosed secure campus is surrounded in natural beauty, greenery, lakes and wildlife. A truly wonderful working environment, along with an extremely supportive team.

Working within a niche sector within the pharmaceutical industry, this opportunity will give the successful candidate a chance to develop themselves and learn new skills that could see them enjoy a highly successful career within a regulated pharmaceutical environment.

Roles and Responsibilities :

  • Provide input to master drug product labelling documents with regards to standard requirements for drug labelling
  • Facilitate alignment of standard labelling statements across labelling documents
  • Responsible for provision of translations of labelling documents
  • Actively advising on the optimal design/layout of presentations of marketed products and products in development

Essential Skills :

  • Intercontinental Region (ICON) labelling experience
  • Co-ordinate the generation and maintenance. May propose draft labelling text during discussions and draft pack content/layout
  • Build and maintain a system that holds up-to-date Master Labels including change history for relevant products
  • Provide advice and counsel on labelling impact/requirements
  • Provide Product Owners with the correct and up-to-date templates for generating country specific labelling documents for submission to Health Authorities (HA)
  • Liaise with cross-functional teams about the lifetime maintenance of the country/ regional approved label
  • Generate, update and maintain product labelling and artwork within assigned region
  • Analyse competitor labelling for products in same class and advise Product Owners to ensure products have most competitive labelling and be aware of recent approvals in class
  • Build and maintain a database that shows current Country Specific artwork including change history for all products
  • Mock-ups and artwork
  • Co-ordinate artwork generation, review, adjustments, decisions, interpreting comments from agency on mock-ups and specimens.

Please apply or call Ben on for more details.

Required skills

  • Icon
  • Officer
  • RA
  • junior
  • regulatory affairs
  • Reg affairs

Reference: 34847888

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