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Senior Director, Regulatory Strategy

On-site in Sant Feliu de Llobregat·Full-time·Added 3 days ago (last checked 26 Oct)

Almirall

41 open roles

Our summary

Work mode
On-site, Sant Feliu de Llobregat
Contract
Full-time
English
Required
Experience
12+ years
Education
University degree

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Skills

Requirements

What we're looking for

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.
  • Fluency in English.

Nice to have

  • Experience in dermatology, immunology, biologics or specialty medicines, application of digital and artificial intelligence tools and in leading a team, would be highly valued.
  • 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.

The role

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.

If you care differently, you belong here.

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.

What you'll do

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.

About Almirall

Almirall is a global pharmaceutical company headquartered in Barcelona, Spain, focused on medical dermatology and skin health. With a presence in over 70 countries and a portfolio spanning prescription drugs, consumer healthcare, and biologics, it is a key player in the dermatology space. The company invests heavily in R&D, particularly in areas like psoriasis, atopic dermatitis, and skin cancer, and operates through a mix of commercial, medical, and research functions.

Almirall's Spain operations are centered in Barcelona, where its global headquarters and major R&D facilities are located. The company offers a multicultural, science-driven environment with opportunities for international professionals in clinical development, regulatory affairs, medical affairs, and digital health. With a strong commitment to innovation and digital transformation, Almirall provides a dynamic setting for those looking to advance their careers in the pharmaceutical industry in Spain.

Industry
Pharma
Founded
1943
Employees
1,000–5,000
Headquarters
Barcelona, Spain
In Spain
Barcelona

Good to know if you are moving

  • Almirall is headquartered in Barcelona, offering a prime location in one of Europe's most attractive cities for international professionals.
  • The company operates in over 70 countries, providing opportunities for cross-border collaboration and career mobility.
  • Almirall has a strong focus on R&D, with significant investment in biologics and digital health, making it an exciting place for scientists and data specialists.
  • The company's work culture emphasizes innovation and international collaboration, with English commonly used in global roles.
  • Barcelona's office serves as the global hub, meaning many roles based there have a global scope and impact.

In their own words

About the company & team

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.

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