Regulatory Affairs Officer – UK Regulations

About the role

The Regulatory Affairs Officer will support clients in navigating UK and European regulatory requirements for medicinal products and sites, ensuring timely submissions and approvals.

Key responsibilities

• Contribute to regulatory activities on the RA Platform/the Hub, covering pre‑licensing, new registrations and post‑licensing submissions.
• Compile and supervise regulatory dossiers to meet national requirements and obtain authority approvals.
• Document, track and manage regulatory submissions and interactions with health authorities on behalf of clients.
• Provide regulatory support to clients and associate companies throughout the product lifecycle.
• Review packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling for format and content.
• Liaise with sponsor head‑office and affiliate departments on regulatory issues.
• Liaise with external regulatory authorities as required.
• Mentor Regulatory Affairs Associates and support project teams to integrate regulatory considerations.
• Enter data into the PLG tool to enable KPI and metric measurement for regulatory services.
• Support the Regulatory Affairs Specialist in generating data needed for project objectives.

Required profile

• 4‑6 years of experience in UK and European regulatory affairs.
• Bachelor’s degree in a science‑related field or equivalent experience.