## ASSOCIATE DIRECTOR, REGULATORY AFFAIRSPresenta candidaturaremote type: R&D; & Medical Affairslocations: SANT FELIU DE LLOBREGATtime type: Full timeposted on: Offerta pubblicata 2 giorni fajob requisition id: 001516Stiamo costruendo il futuro della dermatologia medica concentrandoci sui bisogni ancora insoddisfatti dei pazienti e dando alle persone lo spazio per pensare in modo indipendente, assumersi responsabilità e generare un impatto che conta davvero.

Il nostro purpose è semplice: trasformare la vita dei pazienti rispondendo a bisogni reali.

Lavoriamo con rigore, agiamo con coraggio, teniamo le cose semplici e orientiamo l’innovazione dove può davvero fare la differenza.

Riconosciuti come Top Employer in Spagna dal 2008 e in Germania dal 2025, continuiamo a investire in un ambiente in cui le persone possono crescere e andare avanti.

Se pensi in modo diverso, qui è il posto giusto per te.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 integral 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#J-18808-Ljbffr

📌 Associate Director, Regulatory Affairs (España)
🏢 Almirall
📍 España