Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs

Almirall

Sant Feliu de Llobregat, Spain

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.