SENIOR DIRECTOR, REGULATORY STRATEGY

Almirall; Sant Feliu de Llobregat; On-site; EUR 180,000 - 240,000; Full time

Job summary

Almirall, a leading dermatology-focused pharmaceutical company, seeks a Senior Director, Regulatory Strategy to lead global regulatory strategies from development to registration and lifecycle management.

You will mentor teams, coordinate submissions across EU/US, interface with executives, and shape labeling while anticipating regulatory requirements.

Qualifications

• 12–15+ years in Regulatory Affairs with global submission leadership.
• Experience advancing assets from early development to EU/US approvals.
• Expert knowledge of ICH and US/EU regulatory frameworks.

Responsibilities

• Own global regulatory strategies and roadmaps across priority programs.
• Lead major submissions, scientific advice and clinical trial applications.
• Coordinate HA meetings and responses with cross-functional teams.
• Guide CMC, Nonclinical, and Clinical teams on regulatory expectations.
• Manage risk registers and lifecycle labeling negotiations.
• Support executive interactions and external policy engagement.

Skills

Global submissions leadership

Executive communication

Strategic thinking

Team leadership

English fluency

Education

Advanced degree Life Sciences/Pharmacy/Medicine

Job description

We’rebuilding 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 andfocusour innovation where it makes a difference.

Recognisedas 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.