Regulatory Affairs Manager

Role Overview

• Serve as the primary Regulatory Affairs contact for Clinical Trials, EAP, CUP, and PA-NPP programs across the US, Europe, and Rest of World, providing strategic guidance to internal teams and clients
• Develop and implement regulatory strategies to ensure compliant, timely product access in accordance with destination country requirements
• Lead the preparation, compilation, and submission of regulatory applications to Health Authorities, managing inquiries and correspondence through approval
• Oversee domestic licenses in the US, UK, and Ireland, including managing variations and collaborating with Quality and Supply Chain to ensure regulated activities remain in scope
• Maintain accurate regulatory documentation, intelligence trackers, and project databases, proactively managing regulatory changes and associated risks
• Partner cross-functionally with Medical Affairs, Clinical Operations, Project Management, Quality, Pharmacovigilance, and Supply Chain to support seamless project execution
• Provide regulatory support to investigational sites and contribute expert guidance during project kick-offs, maintenance meetings, and client discussions
• Support Business Development activities, including proposal development, budgeting, and participation in bid defenses
• Identify potential regulatory risks early and implement mitigation strategies to prevent delays or disruptions
• Contribute to team leadership and operational excellence, including line management where applicable, SOP development, Health Authority relationship management, and continuous process improvement initiatives

Requirements

• Bachelor's degree (legal, life sciences, or scientific equivalent preferred)
• 5+ years of broad regulatory experience
• Familiarity with global regulatory frameworks, in particular EU and FDA regulations.
• Understanding and expertise of unlicensed supply (e.g. Expanded Access, Compassionate Use, Named Patient) preferred.
• Experience in developing regulatory strategies
• Ability to communicate within a project setting either to clients or internal key stakeholders, effectively articulate project related matters, risks or updates.
• Strong analytical skills to practically and pragmatically apply regulatory intelligence and to map it onto projects, identifying the critical path, timelines, risks and propose solutions.
• Proven ability to handle multiple projects and priorities in a fast-paced environment.
• Strong problem-solving abilities, being proactive and solution oriented
• Strong organizational skills and attention to detail
• Computer literacy and proficient in Microsoft Office
• Ability to handle confidential information with complete discretion.

Benefits

• Private healthcare insurance
• Long-term illness Cover
• Death in service cover
• Salary sacrifice pension
• Annual leave
• Paid maternity & paternity leave
• Volunteer day