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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 general 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

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📌 ASSOCIATE DIRECTOR, REGULATORY AFFAIRS (Madrid)
🏢 Almirall
📍 Madrid