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Associate Director, Regulatory Affairs

On-site in Sant Feliu de Llobregat·Full-time·Added 2 months ago

Almirall

37 open roles

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Overview

Job details

Full-time hours
Per the ad.

Requirements

Have the right to work in Spain
Almirall doesn't mention sponsorship in the ad.
Work in English
English is required, per the ad.
Work on-site in Sant Feliu de Llobregat
No relocation package mentioned.
Have 8+ years of experience
Director-level role.
University degree
“Bachelor's degree in Life Sciences or Pharmacy; advanced degree preferred” — per the ad.

Requirements

Nice to have

Strong knowledge of EU, US and international regulatory frameworks Excellent project management and organizational skills Strategic thinking and problem-solving capabilities Effective communication and stakeholder management skills Ability to work in cross-functional and multicultural environments

Education & certifications

Bachelor's degree in Life Sciences or Pharmacy; advanced degree preferred Minimum 8 years of experience in Regulatory Affairs within the pharmaceutical industry Proven track record in global regulatory submissions and interactions with health authorities Fluent in English

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.

The Associate Director, Regulatory Affairs is responsible for leading regulatory strategies and operations to support the development, registration, and lifecycle management of Assigned Almirall's pharmaceutical products across global markets. This role ensures regulatory compliance, drives submission excellence, and provides strategic input into cross-functional development plans. The position collaborates closely with internal stakeholders and health authorities to enable timely approvals and maintain regulatory integrity throughout the product lifecycle.

What you'll do

Define and implement global regulatory strategies for development and marketed products Lead the preparation and submission of regulatory dossiers (e.g., CTA, MAA, variations, renewals) in alignment with regional requirements Provide regulatory guidance to cross-functional teams including Clinical, CMC, Safety, and Market Access Manage interactions with health authorities and respond to regulatory queries Ensure compliance with applicable regulations, guidelines, and internal procedures Monitor regulatory changes and assess impact on Almirall's portfolio and operations Support due diligence and licensing activities from a regulatory perspective Contribute to the development and maintenance of regulatory systems, tools, and SOPs Represent Regulatory Affairs in internal governance and decision-making forums

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
Website: almirall.com

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.

All open roles at Almirall