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