Regulatory Affairs Officer (12-month Fixed Term Contract) at BI AH UK Ltd
Bracknell Forest, , United Kingdom -
Full Time


Start Date

Immediate

Expiry Date

20 Nov, 25

Salary

0.0

Posted On

20 Aug, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Pharmaceuticals

Description

THE POSITION

Join our dynamic team as a Regulatory Affairs Officer, where you’ll play a pivotal role in managing product registrations, ensuring compliance with regulatory authorities and Global Regulatory Affairs, and maintaining product licences across the full lifecycle. This role directly impacts both local and global business, requiring dedication, strategic thinking, and accountability.
This is a hybrid role based in Bracknell Head Office on a 12-month Fixed Term Contract.

How To Apply:

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Responsibilities
  • Lead regulatory activities for licensed products in the UK, Ireland, and Malta across the full product life cycle (from pre-launch, launch, maintenance to expiry)
  • Prepare and submit licence variations and implement updates to SPCs, artwork and prescribing information
  • Maintain internal regulatory databases and filing systems
  • Provide expert regulatory input to brand/trial teams and corporate colleagues
  • Stay current with regulatory developments and complete assigned training
  • Support audits, inspections, and investigations of non-compliance
  • Review and provide guidance for promotional materials to ensure regulatory compliance
  • Liaise with external stakeholders to maintain accurate records (e.g. antimicrobial sales reports, NOAH/APHA online compendia, third party archive suppliers)
  • Obtain CPPs and documentation for international product registrations
  • Manage departmental financial processes including purchase orders and invoicing
  • Contribute to process improvements and cross-functional projects
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