Sr. Manager, CTA Regulatory Strategy

We're partnering with a leading global pharmaceutical organisation to identify an experienced Senior Manager, CTA Regulatory Strategy to support the planning, execution, and oversight of Clinical Trial Applications across Europe and other international markets. This is an excellent opportunity to play a key role within a global regulatory team, partnering with Regulatory Leads and cross-functional stakeholders to drive successful clinical trial submissions while ensuring compliance with evolving regulatory requirements. What you'll be doing:

• Support the development and execution of global regulatory strategies for Clinical Trial Applications Lead and coordinate CTA submission activities across the EU, UK, and other regions as required Act as the primary liaison between Regulatory Operations, Clinical teams, affiliates, and Health Authorities Provide strategic regulatory guidance on EU Clinical Trial Regulation (CTR) and UK Clinical Trial legislation Collaborate closely with Global Regulatory Leads to support regulatory planning and regulatory lifecycle activities Oversee CTA deliverables, timelines, quality, and compliance across assigned programmes Drive continuous improvement initiatives, process optimisation, and regulatory operational excellence Support regulatory intelligence activities and evaluate evolving regulatory requirements and guidance Provide functional oversight, coaching, and day-to-day support for external regulatory team members and vendor partners Represent Regulatory
Operations in governance, project, and decision-making meetings, Why this opportunity?
• Join a globally recognised pharmaceutical organisation with strong financial stability Take ownership of high-profile CTA programmes across Europe Work closely with senior global regulatory leadership Influence regulatory strategy and operational excellence initiatives Lead critical submissions supporting innovative clinical development programmes Fully remote opportunity with flexibility across the UK or Germany
Interested or know someone who could be a fit? Feel free to reach out directly or apply confidentially!

What we're looking for:
• Minimum 7 years of Regulatory Affairs experience within the pharmaceutical industry Recent hands-on experience managing Clinical Trial Applications within the EU and UK Strong knowledge of EU Clinical Trial Regulation (CTR) and UK Clinical Trial Regulations First-hand experience using CTIS, IRAS, and associated Health Authority submission portals Experience supporting global regulatory strategy and regulatory submission activities Ability to interpret and apply complex regulatory requirements across development programmes Experience working cross-functionally within global, matrixed environments Strong communication, stakeholder management, and influencing skills Experience working with electronic document management systems (Documentum preferred) Prior experience supervising deliverables, external vendors, consultants, or indirect reports is highly advantageous