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 Intelligence Manager** is responsible for proactively gathering, maintaining, and analysing critical regulatory intelligence related to unlicensed pathways (including EAP, PTA, and PA-NPP), as well as clinical trial and commercial regulatory routes. This role ensures the organisation remains well-informed on evolving regulatory landscapes, emerging trends, and their potential impact on WEP Clinical and its clients. The position also plays a key role in supporting ongoing compliance across WEP Clinical's Managed Access Programmes. ### **The Ideal Candidate:** * Innovative * Strategic * Data driven * Analytical * Detail Oriented * Problem Solver ### **What You'll Do:** * Maintain WEP's regulatory databases, ensuring all country summaries are accurate, up to date, and periodically reviewed. * Conduct in-depth, ad-hoc regulatory research on topics critical to project-specific regulatory strategies. * Monitor and stay current with global regulatory developments via databases, agency websites, industry publications, and expert networks. * Interpret regulatory information, summarising key requirements and implications to inform strategic decisions and project execution. * Collaborate cross-functionally to assess changes in regulatory guidance and communicate critical opportunities or risks to regulatory project leads. * Liaise with and manage vendors responsible for outsourced regulatory intelligence activities, ensuring appropriate project costing and quality delivery. * Communicate with regulatory agencies, as needed, to support the development and accuracy of WEP's regulatory database. * Present changes in regulatory intelligence and their potential impacts to internal stakeholders in a clear, actionable format. * Build and maintain strong relationships with key regulatory contacts, including agencies and vendors, to enhance insights and collaboration. * Support the improvement of WEP's end-to-end regulatory intelligence processes to ensure consistency, accuracy, and reliability. * Identify areas for process optimisation and collaborate with stakeholders to implement compliance-focused solutions. * Contribute to a culture of regulatory excellence by supporting internal knowledge sharing and regulatory awareness initiatives. ### **What You'll Need:** * Bachelor's degree (health or science field preferred). * Minimum of 4 years' experience in regulatory roles related to clinical trials and/or unlicensed supply management. * Strong ability to interpret legislation and assess regulatory requirements. * Skilled in researching complex regulatory topics and summarising findings clearly and accurately. * Proven ability to manage multiple tasks and meet deadlines in a fast-paced environment. * Excellent verbal and written communication skills. * Comfortable managing ambiguity with a flexible approach and the ability to bring structure where needed. * Highly organised with strong attention to detail. * Demonstrated interest in process improvement and operational efficiency. * Proficient in Microsoft Office and general computer literacy. * Self-motivated with strong interpersonal and collaborative skills. * Able to handle confidential information with discretion and professionalism. **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.*