About the job

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
• 
  

What We Offer:

Group Private Medical Insurance

Group General Life Assurance

Group Critical Illness and Group Income Protection<span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559740":240,"335559991":360}"> 

Salary sacrifice pension scheme  

Enhanced maternity & paternity pay

Educational Assistance allowance

Paid volunteering day<span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559740":240,"335559991":360}"> 

What Sets Us Apart:

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.<span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":6,"335551620":6,"335559685":0,"335559737":0,"335559738":0,"335559739":0,"335559740":278}">

We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth, development, and team relationships. Check out our LinkedIn life page to learn more about our team events and all that we do to support our employees.

How We Work at WEP Clinical:

At WEP Clinical, we look for individuals who are conscientious, exercise sound judgement, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives – and we are committed to helping our people grow and succeed in an inclusive, supportive environment.<span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":0,"335559739":0,"335559740":278}"> 

Our Services Include:

Access Programs

Clinical Trial Services

Patient Site Solutions

Clinical Trial Supply

Market Access and Commercialization