Are you driven by the challenge of acting as the primary Regulatory Affairs contact between commercial and local regulatory teams? Do you have a strategic mindset and developed stakeholder management skills?

The position

As the EU Regulatory Affairs Director, you will act as a formal point of Regulatory Affairs (RA) contact for the Head of Commercial Operations Europe and local EU RA teams. You will develop, maintain and drive integral regulatory overview and integrated regulatory plans that support the timely development, registration, lifecycle management, and commercialization of pharmaceutical products across EU.

Your primary tasks will be:

- Guide and oversee EU RA strategies through support to regulatory scenario planning and assessment of alternative submission strategies.
- Coordinate and sequence regulatory work across the EU for highest-value impact and effective use of resources.
- Facilitate cross-functional meetings and ensure alignment of regulatory deliverables and timelines.




- Consolidate and communicate EU regulatory intelligence.
- Represent RA in the Marketed Products Committee (MPC): Provide regulatory input to cases, secure decisions, and oversee execution.
- Develop and own a framework for prioritizing RA resources across maintenance, LCM, and pipeline; Align recommendations with commercial and R&D; priorities.
- Maintain a consolidated global RA resource/FTE/cost/timeline view, produce forecasts and dashboards, and recommend allocations and trade-offs.
- Prepare strategic RA communications and inputs for MPC, PPPCom, and executive leadership on regulatory matters.
- Act as regulatory representative in business development activities.
- Coordinate and provide input to new business opportunities and budgets and advise on regulatory timelines and specifications.

This is a truly global role with stakeholders across Euro

📌 EU Regulatory Affairs Director (España)
🏢 ALK
📍 España