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.

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).

• Innovative
• Strategic
• Data driven
• Analytical

• 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

• 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

• 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

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.

Check out our Linked In life page to learn more about our team events and all that we do to support our employees.

At WEP Clinical, we look for individuals who are…