OverviewIn this role you lead global regulatory strategies for priority programs from early development to registration and lifecycle management.
You shape development plans, labels, and high-quality submissions while coordinating health authority engagements across regions.
You mentor regulatory strategists to ensure consistency and excellence and contribute to external policy discussions.
You work closely with cross-functional partners to align regulatory goals with business priorities.
ResponsabilidadesOwn global regulatory strategies and roadmaps aligned with therapeutic and commercial goals
Lead preparation of major submissions, scientific advice, and clinical trial applications; coordinate health authority meetings
Guide cross-functional teams on regulatory expectations (CMC/Nonclinical/Clinical) and documentation standards
Manage risk registers, mitigation plans, and lifecycle labeling negotiations




Develop function capability through coaching, standards, and best practices
Manage high-level interactions with Executive Management and stakeholders
Requisitos principales*+ years in Regulatory Affairs with global submission leadership
Experience advancing assets from early development through regulatory approval in the EU and US
Expert knowledge of ICH and regional frameworks (US/EU/ROW)
Exceptional communication, influence, and strategic thinking
Experience in dermatology, immunology, biologics or specialty medicines; familiarity with digital and AI tools; leadership experience
Fluency in English
exceptional communication
influence
strategic thinking
general regulatory submissions
HC authority engagements
CMC/Nonclinical/Clinical coordination

📌 Senior Director, Regulatory Strategy (Barcelona)
🏢 Almirall
📍 Barcelona