Regulatory Affairs Pharmacists >
Description.
Support regulatory submissions, compliance activities, and lifecycle management of medicinal products within MHRA- and EMA-regulated environments. Contribute to dossier preparation, labelling compliance, variations, renewals, and regulatory strategy to ensure products remain safe, effective, and compliant.
Key Requirements.
Experience.
Minimum 1 year’s post-registration experience in regulatory affairs within the pharmaceutical sector.
Skilled in preparing regulatory documentation, reviewing technical files, and supporting submissions for new products and post-marketing changes.
Experience liaising with MHRA, preparing variations, managing renewals, and supporting regulatory responses.
Confident working with cross-functional teams including quality, manufacturing, medical, and regulatory operations.
Qualifications.
MPharm degree (or recognised equivalent) with full GPhC registration.
Postgraduate training in Regulatory Affairs, Pharmaceutical Sciences, or Quality Systems desirable.
CPD in regulatory frameworks, MHRA/EMA requirements, and pharmaceutical compliance.
Compliance and Vetting.
Enhanced DBS on the Update Service.
Full identity and right-to-work verification.
Two recent professional references.
Up-to-date mandatory training relevant to industry and office-based settings.
Full GPhC registration and fitness-to-practise check.
Verification of qualifications and employment history.