WEP Clinical
Regulatory Affairs Manager
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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. \n
The Ideal Candidate: Innovative Strategic Data driven Analytical
What You'll Do: 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
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What You'll Need: 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.
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\n What We Offer: Private healthcare insurance Long-term illness Cover Death in service cover Salary sacrifice pension Annual leave Paid maternity & paternity leave Volunteer day What Sets Us Apart: WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs. We're Committed to Our Team: WEP has many initiatives to encourage wellness, growth, development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events and all that we do to support our employees. We're Committed to DEI: At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities. Our services include: Access Programs Clinical Trial Services Patient Site Solutions Clinical Trial Supply Market Access and Commercialisation WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment. WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
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