The Role
Lead global regulatory strategy and operational oversight for Expanded Access, Open Label Extension, and Post-Approval Named Patient Programs. Provide regulatory guidance across US, EU, UK, and other regions; maintain US licenses; engage regulatory authorities; support internal projects and client proposals; and manage, train, and develop Regulatory Affairs staff.
Summary Generated by Built In
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).
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
Salary sacrifice pension scheme
Enhanced maternity & paternity pay
Educational Assistance allowance
Paid volunteering day
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.
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.
Our Services Include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
Data Privacy Notice:
WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.
Privacy Policy: https://www.wepclinical.com/privacy-policy/
Job Applicant Privacy Notice: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/
How to Apply:
To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.
Important Note:
To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page.
For Your Safety, Please Note:
We will never communicate with you via Microsoft Teams or text message.
We will never ask for your bank account information at any stage of recruitment.
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
#LI-fulltime #LI-hybrid
Skills Required
- Bachelor's degree in legal, life sciences, or a scientific equivalent
- 7+ years of broad regulatory experience
- Exposure to Expanded Access, Compassionate Use, Open Label Extension, and Post-Approval Named Patient Programs
- Effective verbal and written communication skills
- Strong organizational skills and attention to detail
- Computer literacy and proficiency in Microsoft Office
- Ability to handle extremely confidential information with complete discretion
- Experience developing regulatory strategy
- Ability to manage multiple tasks and deadlines accurately
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The Company
What We Do
We are a rapidly growing niche pharmaceutical services company operating in four key sectors:- Managed Access Programs (MAP) Unlicensed Medicines Access Clinical Trial Sourcing Reference Product Supply. Our goal is to provide positive measurable outcomes to patients and sponsors but above all else we want to be known as your “trusted partner” and an extension of your team. •UK headquarters established in London in 2008. •US Headquarters established in Research Triangle Park, North Carolina in 2012. •Our team has many years of pharmaceutical, clinical and regulatory experience gained in companies such as Pfizer, AZ, MSD, GSK, UDG Healthcare, Waymade, Sanofi, Quintiles & Walgreens Boots Alliance. •Our facilities have been inspected & licensed by the MHRA, UK Home Office, FDA and all necessary local approval bodies. •We are also approved to handle and distribute controlled substances. •We are compliant with all relevant GMDP regulations and operate to a high standard of medicines supply. •We operate under a comprehensive Quality Management System with robust and compliant standard operating procedures (SOPs) and policies. •Our customers and partners include Pharma, Biotechs, Generic and Biosimilar Developers, CROs and Healthcare and Hospital authorities. •We are fully committed to a culture of continual development and strive to service our partners needs beyond their expectations We would be happy to answer any questions that you may have regarding WEP Clinical and our products and services.
