Senior Regulatory Affairs Manager

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 Programme, Expanded Access Programme, Compassionate Use Programme, 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.

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• Serve as the primary Regulatory Affairs contact for Clinical Trials, EAP, CUP, and PA‑NPP projects across US, Europe, & 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.
  
• Innovative
  
• Strategic
  
• Data driven
  
• Analytical
  
• Detail Oriented
  
• Problem Solver, 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.
  

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.

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.

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.

WEP Clinical is a smoke‑free, drug‑free, and alcohol‑free work environment.

Equal‑opportunity employer
WEP Clinical does not unlawfully discriminate against employees or applicants for employment on the basis of any protected status. 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.

£41,520 per year – estimated salary. Full time. Remote. NEW