Regulatory Affairs Officer
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
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.
- regulatory affairs
- Reg affairs
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