Are you looking for an exciting and fulfilling new position? 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 ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives.

QUALIFICATIONS:

• Bachelor’s degree (legal, life sciences, or scientific equivalent preferred)
• 3+ years of broad regulatory experience
• Familiarity with global regulatory frameworks, in particular EU and FDA regulations.
• Understanding and expertise of unlicensed supply (e.g. Expanded Access, Compassionate Use, Named Patient) preferred.
• Experience in developing regulatory strategies
• Ability to communicate within a project setting, either to clients or internal key stakeholders, effectively articulate project-related matters, risks or updates.
• Strong analytical skills to practically and pragmatically apply regulatory intelligence and map it onto projects, identifying the critical path, timelines, risks and proposing solutions.
• Proven ability to handle multiple projects and priorities in a fast-paced environment.
• Strong problem-solving abilities, being proactive and solution-oriented
• Strong organisational skills and attention to detail
• Computer literacy and proficient in Microsoft Office
• Ability to handle confidential information with complete discretion

ROLE OBJECTIVES:

As a Project Manager, you will play a vital role in getting medicines to patients who have exhausted all viable options. You will be responsible for setting up, implementing, and managing individual Expanded Access Programs.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Serve as the main point of contact for ongoing Clinical Trial, EAP, CUP, and PA-NPP Regulatory Affairs matters (US, Europe, and ROW), leveraging and interpreting existing intelligence sources and databases to provide pragmatic advice and guidance to WEP colleagues and clients and drive the completion of related project activities.
• Develop robust regulatory strategies to ensure compliant and timely access to products compliant with the destination country’s regulatory requirements.
• Provide regulatory support to sites requiring specific regulatory guidance to facilitate product supply.
• Maintain accurate and up-to-date regulatory documentation and databases specific to the projects.
• Manage changes impacting your projects from a regulatory perspective, clearly communicating the impact and working with the key stakeholders to ensure completion of critical activities to avoid disruption.
• Participate in project kick-off and maintenance meetings, providing status updates and confidently addressing any queries relating to regulatory matters.
• Support the Business Development team and assist in client bid-related activities such as budget development, proposals and bid defences.
• Oversee domestic licenses (US, UK, and IE) in collaboration with key departments (Quality and Supply Chain) to ensure regulated activities are within the scope of existing licenses. Where required, put in relevant variations to the Health Authorities, and ensure risks and timelines for variations are understood and can be met.
• Lead and manage the preparation, compilation, and submission of regulatory applications for related projects (e.g., CUP/EAP and/or CT applications) to relevant Health Authorities (e.g., MHRA, ANSM, FDA, national competent authorities), on time.
• Coordinate with internal teams (Medical Affairs, Supply Chain, Quality, Project Management) to gather PAGE 2 OF 4 necessary documentation and data for submissions within agreed timelines.
• Manage regulatory inquiries and correspondence from Health Authorities regarding these projects, ensuring questions can be addressed.
• Proactively address potential issues and risks before submission to Health Authorities, and have appropriate risk mitigation strategies in place to address the risks.
• Serve as the primary Regulatory Affairs point of contact for internal stakeholders involved in related projects, providing expert regulatory guidance and solutions.
• Collaborate with key stakeholders, such as Medical Affairs, Project Management, Clinical Operations, Quality, Pharmacovigilance, and Supply Chain, to ensure seamless project coordination and execution.