Senior Manager, CTA Regulatory Strategy in Newcastle upon Tyne

Senior Manager, CTA Regulatory Strategy | EU & UK

We're looking for an experienced Senior Manager, CTA Regulatory Strategy to play a key role in shaping and executing global regulatory strategy for clinical trial applications.

This is an excellent opportunity for a regulatory professional with strong EU and UK CTA experience to take a strategic role within a global, collaborative regulatory environment.

You'll work closely with Regulatory Affairs, Clinical, Medical Writing, CMC and other cross-functional teams, while acting as a key point of contact for Health Authorities, affiliates and external partners.

The Role

You'll be responsible for supporting the development and execution of global regulatory strategies for assigned Clinical Trial Application (CTA) projects, with a particular focus on the EU and UK.

You'll oversee submission activities throughout the regulatory lifecycle, provide strategic input on complex regulatory matters, and ensure submissions are delivered to a high standard and within agreed timelines.

Key Responsibilities

• Support the development and execution of global regulatory strategies and plans for Clinical Trial Applications.
• Lead and coordinate CTA activities across the EU, UK and other international markets as required.
• Act as a key liaison between Regulatory Operations, Clinical Management and other internal stakeholders.
• Work closely with affiliates, collaborators and external vendors to plan, prepare and submit CTAs to Health Authorities.
• Serve as a primary contact for Health Authorities across the EU, UK and other regions.
• Provide strategic input on submission documents and help address complex global regulatory requirements and Health Authority queries.
• Apply regulatory intelligence to identify innovative regulatory pathways and solutions.
• Manage electronic submission and lifecycle activities, including continuous improvement of regulatory processes and systems.
• Oversee project teams and vendor partners to ensure high-quality, compliant submission deliverables.
• Ensure regulatory activities meet applicable local requirements and electronic submission standards.
• Contribute to process improvement initiatives, process mapping and the development of regulatory work instructions.
• Collaborate across a global, matrixed organisation to deliver multiple regulatory initiatives simultaneously.
• Key Requirements
• 7+ years of regulatory strategy/regulatory affairs experience within the pharmaceutical industry.
• Recent, hands-on experience managing Clinical Trial Applications in the EU and UK is essential.
• Strong knowledge of the EU Clinical Trial Regulation (CTR) and UK clinical trial regulations, including the 2025 UK CTR amendments.
• Proven first-hand experience with electronic submissions through CTIS, IRAS and other Health Authority portals.
• Experience supporting global pharmaceutical development and regulatory lifecycle activities.
• Strong understanding of regulatory strategy and the ability to provide strategic input into key submission documents.
• Excellent communication and influencing skills, with the confidence to engage directly with Regulatory Authorities and senior internal stakeholders.
• Strong knowledge of electronic regulatory submission processes and Document Management Systems; Documentum experience is preferred.
• Strong Microsoft Office and Share Point skills.
• Experience developing and improving regulatory processes across multiple functions.
• Ability to manage complex, time-sensitive deliverables within agreed timelines and budgets.
• Experience working with external vendors/outsourcing partners.
• Strong problem-solving, project management and stakeholder management capabilities.
• Ability to operate effectively within a global, matrixed and multicultural environment.