
Regulatory Affairs Officer
- Bracknell, Berkshire
- Contract
- Full-time
- 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
- 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
We are sorry but this recruiter does not accept applications from abroad.