- Location
- SANT FELIU DE LLOBREGAT, Spain
- Type
- Full-time
- Department
- Legal
- Seniority
- Senior
- Source
- Workday
Description
We’re building the future of medical dermatology by focusing on unmet patient needs and giving people the space to think independently, take ownership and make an impact that matters.
Our purpose is simple: to transform patients’ lives by addressing real needs. We work with care, act with courage, keep things simple and focus our innovation where it makes a difference.
Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we continue to invest in an environment where people can grow and move forward.
If you care differently, you belong here.
POSITION SUMMARY / MISSION
The Senior Director, Regulatory Strategy leads global regulatory strategies for priority programs from early development through registration and lifecycle. The role anticipates requirements, shapes development plans and labels, and orchestrates high-quality submissions and health authority engagements across regions.
The incumbent mentors’ regulatory strategists drive consistency and excellence, and influences external policy discussions where relevant.
CORE RESPONSIBILITIES
- Own global regulatory strategies and roadmaps; align with TPP and commercial goals.
- Lead preparation of major submissions, scientific advice and clinical trial applications; coordinate HA meetings and responses.
- Guide cross-functional teams on regulatory expectations (CMC / Nonclinical / Clinical) within the company and with partners, and documentation standards.
- Manage risk registers and mitigation; support labeling negotiations and lifecycle planning.
- Develop capability within the function of coaching and standards
- Manage internal and external high-level interactions with Executive Management and stakeholders.
REQUIRED EDUCATION AND EXPERIENCE
- Advanced degree in Life Sciences/Pharmacy/Medicine
12–15+ years in Regulatory Affairs with global submission leadership. - Demonstrated experience advancing assets from early development through regulatory approval in the EU and the 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, application of digital and artificial intelligence tools and in leading a team, would be highly valued.
- Fluency in English.
PREFERRED SKILLS AND COMPETENCIES
- Strategic, business-oriented and patient-centric leader, able to influence senior stakeholders, collaborate in matrix environments and operate effectively in an international setting.
- Experience with expedited pathways and complex modalities.
- External policy/industry working group participation.
- Inspection/due diligence experience.