regulatory affairs officer in borehamwood

posted
job type
permanent
salary
£ 27,000 per year
apply now

job details

posted
location
borehamwood, hertfordshire
job category
pharmaceutical
job type
permanent
salary
£ 27,000 per year
reference number
Pelstb-RegAffOff
phone
0208 957 2606
apply now

job description

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 02085972606 for more details.

skills

Reg affairs, regulatory affairs, RA, Officer, junior, Icon