Associate Director, Regulatory Affairs

Are you seeking an exciting and fulfilling new opportunity? 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 forward 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 Associate Director of Regulatory Affairs is responsible for understanding, developing, and leading the Regulatory Affairs strategy for Global Expanded Access Programs (EAP), Open Label Extension (OLE), and Post-Approval Named Patient Programs (PA-NPP). The Ideal Candidate: Innovative Strategic Data driven Analytical What You'll Do: Provide Regulatory operational oversight and support to expedite the development and delivery of safe and effective healthcare products to individuals around the world. Provide guidance regarding current EAP, OLE and PA-NPP regulations and guidance (US, EU, UK and ROW) Provide guidance and support with regards to domestic licence regulations and requirements. Maintain domestically held licences from the competent authorities (US) Oversee the development of global, regional, and multi-country strategies and update based upon regulatory changes. Interact with regulatory authorities during the EAP, OLE and NPP review process to ensure approval. Responsible for the successful delivery of regulatory guidance for internal projects teams. Responsible for the line management of Regulatory Affairs staff including leadership, oversight, training, and development. Responsible for building and maintaining positive client relationships. Assist in the development and delivery of proposals in bid defences and capability presentations to perspective clients as the representative for WEP Clinical Regulatory Affairs What You'll Need: Bachelor’s degree (legal, life sciences, or scientific equivalent preferred). 7+ years of broad regulatory experience. Exposure to Expanded access, Compassionate use, Open Label Extension, and Post Approval Named Patient programs preferred. Effective verbal and written communication skills Strong organizational skills and attention to detail Computer literacy and proficient in Microsoft Office Ability to handle extremely confidential information with complete discretion Previous experience in developing regulatory strategy Pro-active and solutions driven, with ability to meet multiple tasks and deadlines with a high level of accuracy What We Offer: Group Private Medical Insurance Group General Life Assurance Group Critical Illness and Group Income Protection Salary sacrifice pension scheme Enhanced maternity & paternity pay Educational Assistance allowance Paid volunteering day What Sets Us Apart: WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalised service of a specialised provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments. 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. How We Work at WEP Clinical: At WEP Clinical, we look for individuals who are conscientious, exercise sound judgement, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives – and we are committed to helping our people grow and succeed in an inclusive, supportive environment. Our Services Include: Access Programs Clinical Trial Services Patient Site Solutions Clinical Trial Supply Market Access and Commercialization Data Privacy Notice: WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice. Privacy Policy: https://www.wepclinical.com/privacy-policy/ Job Applicant Privacy Notice: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/ How to Apply: To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English. Important Note: To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page ( https://www.wepclinical.com/careers/ ) or our verified LinkedIn page. For Your Safety, Please Note: We will never communicate with you via Microsoft Teams or text message. We will never ask for your bank account information at any stage of recruitment. 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. #LI-fulltime #LI-hybrid