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.
KEY 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
WHAT WE'RE LOOKING FOR
* Degree in a relevant scientific discipline
* Regulatory or technical experience in pharma (preferred but not essential)
* Strong planning and prioritisation skills with a proactive, flexible mindset
* Ability to manage a varied workload and adapt to changing deadlines
* Independent worker with sound judgment and team spirit
* Excellent written communication and attention to detail
* Strong interpersonal skills to engage internal and external stakeholders
* Confident with IT systems and databases
WHY THIS IS A GREAT PLACE TO WORK
Boehringer Ingelheim has been recognised as a Top Employer in the UK. Being certified as a Top Employer confirms our dedication to a better world of work, delivered through excellent HR policies and people practices. To learn more visit: https://www.boehringer-