ASSOCIATE DIRECTOR, REGULATORY AFFAIRS

Almirall Sa; Sant Feliu de Llobregat; Presencial; EUR 90.000 - 140.000; Jornada completa

Descripción de la vacante

Almirall SA in Sant Feliu de Llobregat seeks an experienced Associate Director, Regulatory Affairs to lead global regulatory strategies and submissions for our dermatology portfolio.

You will collaborate with Clinical, CMC, Safety and Market Access teams, coordinate CTAs, MAAs, variations, and renewals, and interact with health authorities to ensure timely approvals and lifecycle management.

Formación

• Bachelor's degree in Life Sciences or Pharmacy; advanced degree preferred.
• 8+ years regulatory affairs experience in pharma with global submissions.
• Fluent in English and experience interacting with health authorities.

Responsabilidades

• Define and implement global regulatory strategies for development and marketed products.
• Lead preparation and submission of regulatory dossiers (CTA, MAA, variations, renewals).
• Provide regulatory guidance to cross-functional teams (Clinical, CMC, Safety, Market Access).
• Manage health authority interactions and respond to regulatory queries.
• Ensure compliance with regulations and monitor regulatory changes.

Conocimientos

Regulatory strategy

Submission management

Project management

Stakeholder management

Cross-functional collaboration

Educación

Bachelor's degree in Life Sciences or Pharmacy

Advanced degree preferred

Descripción del empleo

## ASSOCIATE DIRECTOR, REGULATORY AFFAIRSSolicitarremote type: R&D & Medical Affairslocations: SANT FELIU DE LLOBREGATtime type: Full timeposted on: Publicado hace 4 díasjob requisition id: 001516Estamos construyendo el futuro de la dermatología médica centrándonos en las necesidades no cubiertas de los pacientes y dando a las personas el espacio para pensar de forma independiente, asumir responsabilidades y generar un impacto que de verdad importe.Nuestro propósito es sencillo: transformar la vida de los pacientes abordando necesidades reales. Trabajamos con rigor, actuamos con valentía, simplificamos lo complejo y enfocamos la innovación allí donde realmente marca la diferencia.Reconocidos como Top Employer en España desde 2008 y en Alemania desde 2025, seguimos invirtiendo en un entorno donde las personas pueden crecer y avanzar.Si quieres hacer las cosas de otra manera, este es tu lugar.POSITION SUMMARY / MISSIONThe 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 RESPONSIBILITIESDefine 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 forumsREQUIRED EDUCATION AND EXPERIENCEBachelor’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 EnglishPREFERRED SKILLS AND COMPETENCIESStrong 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