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About the Role

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).

Responsibilities

• Provide Regulatory operational oversight and support to expedite the development and delivery of safe and effective healthcare products.
• 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.

Requirements

• 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.

Skills

• Innovative
• Strategic
• Data driven
• Analytical

Work Type

• full-time
• hybrid

Education Level

• Bachelor’s degree (legal, life sciences, or scientific equivalent preferred)

Benefits

• 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

About the Company

• 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.
• WEP has many initiatives to encourage wellness, growth, development, and team relationships.
• 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.

Equal Opportunity

• 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.