Job Description

Regulatory Affairs Manager - Clinical Trials/unlicensed supply management

Location: Hybrid/Remote
Job Type: Permanent, Full-time

Experienced Regulatory Affairs Manager required to join a fast-moving, patient-focused environment, supporting international access to unlicensed and investigational medicines. The successful candidate will lead and deliver regulatory activities across Expanded Access Programmes (EAPs), Compassionate Use Programmes (CUPs), Named Patient Programmes (NPPs), and Clinical Trials.

Key Responsibilities:

• Lead global regulatory strategy and submissions for early access and post-approval access programmes.
• Prepare and manage applications to regulatory authorities (eg, MHRA, EMA, FDA).
• Provide regulatory advice to internal teams and external partners.
• Maintain regulatory documentation and oversee compliance.
• Support cross-functional project delivery across Regulatory, Medical Affairs, Supply Chain, and Quality.
• Contribute to bid/proposal development and client discussions.
• Support and manage UK/US/IE licences and associated variations.
• Line management of junior regulatory staff (if applicable).

Essential Skills & Experience:

• Extensive experience in regulatory affairs.
• Degree in life sciences, pharmacy, law or a related discipline.
• Strong knowledge of EU and US regulatory requirements.
• Experience with unlicensed medicines supply (EAPs, NPPs, CUPs) highly desirable.
• Confident communicator with strong problem-solving skills.
• Ability to manage multiple projects and priorities.

Desirable:

• Experience working with Health Authorities on early access or clinical trial applications.
• Familiarity with compliance processes and SOP development.

This is an excellent opportunity for a regulatory professional who is motivated by meaningful work that directly impacts patient lives. The organisation fosters a collaborative and supportive culture, where initiative and expertise are valued.