Regulatory Affairs Associate

Regulatory Affairs & Pharmacovigilance Associate:

• Permanent, Full-Time
• 100% On-Site
• Based in Hertfordshire
• £30,000 to £32,000 DOE I'm working with a fast-growing, ambitious UK pharmaceutical company that develops, manufactures and markets prescription-only medicines for hospitals, wholesalers and pharmacies, with a growing presence in other international markets. They're looking for a Regulatory Affairs & Pharmacovigilance Associate to support both teams with day-to-day activities. It's a great opportunity for an early-career scientist to build broad experience across regulatory affairs and pharmacovigilance (PV) in a hands-on, growing business. What you'll be doing: Regulatory Affairs
• Supporting the preparation, submission and maintenance of Marketing Authorisations (MAs)
• Helping compile and publish eCTD dossier documentation
• Maintaining regulatory files, databases and tracking systems
• Communicating MA changes to internal teams and external partners
• Supporting packaging and labelling updates with designers, suppliers and partners
• Monitoring global regulatory intelligence
• Helping develop and maintain regulatory SOPs and processes Pharmacovigilance
• Supporting oversight of the outsourced PV service provider
• Helping prepare and review updates to the PSMF
• Supporting the preparation and tracking of Safety Data Exchange Agreements (SDEAs)
• Assisting with PV audits, follow-up actions and audit records
• Supporting reconciliation activities and medical information enquiries What they're looking for:
• A Bachelor's degree, ideally in a science, engineering, public health or medical writing discipline
• Pharmaceutical industry experience is a plus, but not essential
• Excellent written and verbal communication skills
• Someone organised and proactive, who can manage their own day-to-day workload
• An interest in building knowledge of regulatory frameworks such as ICH, EMA, GVP and MHRA Interested? Apply directly or send across your updated cv to d.jones@x4lifesciences.com