ASSOCIATE DIRECTOR, REGULATORY AFFAIRS

Almirall; Sant Feliu de Llobregat; On-site; EUR 90,000 - 130,000; Full time

Job summary

Almirall is seeking an Associate Director of Regulatory Affairs to lead global regulatory strategies and oversee submissions for development and marketed products. You will partner with Clinical, CMC, Safety, and Market Access teams to ensure timely approvals and lifecycle management across markets.

The role requires strong regulatory leadership, extensive experience with EU/US frameworks, and excellent stakeholder management in a fast-paced, cross-cultural environment.

Qualifications

• 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.

Responsibilities

• Define and implement global regulatory strategies for development and marketed products.
• Lead the preparation and submission of regulatory dossiers (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.

Skills

Regulatory Strategy

Global Submissions

Stakeholder Management

Cross-functional Leadership

English Proficiency

Project Management

Education

Bachelor’s degree in Life Sciences or Pharmacy

Advanced degree in a related field

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 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.

CORE RESPONSIBILITIES

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

REQUIRED EDUCATION AND EXPERIENCE

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

PREFERRED SKILLS AND COMPETENCIES

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