Wepclinical2mo ago

Regulatory Affairs Manager

United KingdomFull-Timemid

OtherRegulatory Affairs Manager

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Quick Summary

Overview

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical,

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Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives.

Role Objectives:

The WEP Clinical Regulatory Affairs Manager plays a pivotal role in developing, executing and supporting the regulatory strategy with respect to the various projects managed by WEP Clinical (primarily Post-Approval Named Patient Programs, Expanded Access Programs, Compassionate Use Programs, and Clinical Trials).

The Regulatory Affairs Manager will be responsible for managing regulatory submissions, ensuring compliance, and providing expert regulatory guidance to enable timely access to medicines for patients with urgent unmet medical needs across various global markets. The Regulatory Affairs Manager will be a key contributor to WEP Clinical projects, working closely with cross-functional teams to navigate complex and unique regulatory pathways.

Innovative

Strategic

Data driven

Analytical

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

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.