At a Glance
- Tasks: Lead regulatory strategy for global healthcare programs and ensure compliance with regulations.
- Company: Join WEP Clinical, a mission-driven organisation transforming lives through clinical research.
- Benefits: Enjoy private medical insurance, life assurance, pension scheme, and enhanced maternity leave.
- Other info: Dynamic team environment with opportunities for professional growth and development.
- Why this job: Make a real impact in healthcare while driving innovation and collaboration.
- Qualifications: Bachelor's degree and 7+ years of regulatory experience required.
The predicted salary is between 63000 - 77000 £ per year.
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).
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 What We Offer Group Private Medical Insurance Group General Life Assurance Group Critical Illness and Group Income Protection Salary sacrifice pension scheme Enhanced maternity
Associate Director, Regulatory Affairs employer: Wepclinical
WEP Clinical is an exceptional employer that fosters a collaborative and innovative work culture, where experienced professionals can thrive in their roles. With a strong focus on employee growth and development, the company offers ample opportunities for career advancement while working on impactful projects in the clinical trials sector. Located in a dynamic environment, WEP Clinical provides a unique chance to engage with global partners and contribute to meaningful healthcare solutions.
