Senior Regulatory Affairs Manager

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.

Role Objectives

The WEP Clinical Senior Regulatory Affairs Manager plays a critical role in shaping and delivering regulatory strategies across a diverse portfolio of projects, including Post-Approval Named Patient Programmes, Expanded Access Programmes, Compassionate Use Programmes, and Clinical Trials. This role is responsible for managing regulatory submissions, ensuring global compliance, and providing expert regulatory guidance to support timely access to medicines for patients with urgent unmet medical needs. The Regulatory Affairs Manager will collaborate closely with cross-functional teams and be a key contributor in navigating complex and evolving regulatory landscapes across international markets.

The Ideal Candidate

• Innovative
• Strategic
• Data driven
• Analytical
• Detail Oriented
• Problem Solver

What You'll Do

• Serve as the primary Regulatory Affairs contact for Clinical Trials, EAP, CUP, and PA NPP projects across US, Europe, and ROW, providing expert guidance to WEP colleagues and clients.
• Develop and implement regulatory strategies ensuring compliant and timely product access aligned with destination country requirements.
• Manage preparation, compilation, and submission of regulatory applications (e.g., CUP/EAP, clinical trial applications) to relevant Health Authorities such as MHRA, FDA, ANSM, and others.
• Oversee domestic licences (US, UK, IE), coordinating with Quality and Supply Chain to ensure regulatory compliance and manage variations as needed.
• Maintain up to date regulatory documentation and databases specific to projects.
• Proactively manage regulatory changes impacting projects, communicating impacts and collaborating with stakeholders to mitigate risks and avoid disruptions.
• Coordinate with cross functional teams (Medical Affairs, Supply Chain, Quality, Project Management) to gather documentation and ensure timely regulatory submissions.
• Manage regulatory inquiries and correspondence from Health Authorities, ensuring timely and accurate responses.
• Participate in project meetings, providing regulatory status updates and addressing queries.
• Support Business Development with bid activities including budget development, proposals, and bid defences.
• Collaborate with internal stakeholders to ensure seamless project execution and contribute regulatory insights in cross functional teams.
• Lead, mentor, and develop Regulatory Affairs staff, and contribute to drafting and maintaining regulatory policies, SOPs, and continuous improvement initiatives.

What You'll Need

• Bachelor's degree (legal, life sciences, or scientific equivalent preferred).
• Minimum 4 8 years of broad regulatory experience.
• Familiarity with global regulatory frameworks, especially EU and FDA regulations.
• Understanding of unlicensed supply pathways (e.g., Expanded Access, Compassionate Use, Named Patient) preferred.
• Experience developing and implementing regulatory strategies.
• Strong communication skills, capable of effectively articulating project matters, risks, and updates to clients and internal stakeholders.
• Excellent analytical skills to apply regulatory intelligence pragmatically, identifying critical paths, timelines, risks, and solutions.
• Proven ability to manage multiple projects and priorities in a fast paced environment.
• Proactive problem solver with a solutions oriented mindset.
• Highly organised with strong attention to detail.
• Proficient in Microsoft Office and computer literate.
• Ability to handle confidential information with complete discretion.

What We Offer

• Private healthcare insurance
• Long term illness Cover
• Death in service cover
• Salary sacrifice pension
• Annual leave
• Paid maternity & paternity leave
• Volunteer day

What Sets Us Apart

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

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.

We're Committed to DEI

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.

Our services include

• Access Programs
• Clinical Trial Services
• Patient Site Solutions
• Clinical Trial Supply
• Market Access and Commercialisation

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.