X4 Life Sciences
Regulatory Affairs Associate
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Regulatory Affairs & Pharmacovigilance Associate
Permanent, Full-Time
100% On-Site
Based in Hertfordshire
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
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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
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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 organized 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
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