Associate Director, Regulatory Affairs

Job description

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