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