Regulatory Project Manager

Please note that the successful candidate can work from our offices in Belfast, Barcelona or London

The Opportunity

We’re looking for a highly organised and proactive Technical Project Manager to support global product submissions within a fast-paced pharmaceutical environment. This role sits at the intersection of Technical Development and Regulatory Affairs, ensuring critical documentation is delivered accurately and on time to meet accelerated filing timelines.

If you thrive on complexity, enjoy cross-functional collaboration, and have experience in CMC or pharmaceutical manufacturing, this is a high-impact opportunity to drive global delivery excellence.

What You’ll Be Doing

• Own and manage a global tracking system for critical source documents, including timelines, ownership, and dependencies
• Provide a single source of truth for document status, progress, and risks
• Build dashboards and perform trend analysis to track delivery performance
• Identify critical paths, risks, and bottlenecks, and drive mitigation actions
• Lead day-to-day follow-up on high-priority deliverables to ensure deadlines are met
• Oversee document lifecycle processes (authoring, review, approval, version control)
• Coordinate cross-functional teams across technical and regulatory functions
• Deliver clear and actionable reports and updates to stakeholders

What Success Looks Like

• Seamless coordination of document delivery across global teams
• Early identification and resolution of risks impacting submissions
• Improved efficiency in document review and approval cycles
• On-time delivery of high-quality regulatory submission packages

What You Bring

Essential

• Experience in CMC, biochemistry, or pharmaceutical/vaccine manufacturing
• Strong understanding of regulatory submissions and dossier preparation
• Proven project management expertise, including planning, tracking, and reporting
• Excellent communication skills in English (written and verbal)

• French language skills are highly desirable
• Experience with tools such as MS Project or Planisware
• Familiarity with document management systems (e.g. Veeva, Documentum)
• Previous experience in a large global pharmaceutical environment

Why Join

• Work on high-impact, global regulatory projects
• Collaborate with cross-functional scientific and regulatory teams
• Gain exposure to end-to-end product lifecycle processes
• Be part of a fast-paced, delivery-focused environment where your work directly contributes to bringing products to market

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