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POSITION SUMMARY / MISSION
The Regulatory Affairs Manager, part of the Regulatory Operations Department, is responsible for supporting regulatory activities that ensure successful life-cycle management of Almirall's global legacy products. This role involves leading post-approval regulatory processes across international markets, ensuring compliance with local regulations, and collaborating closely with Almirall's market companies, strategic partners, and local consultants.

CORE RESPONSIBILITIES

• Execute regulatory strategies and submission plans for post-approval changes and responses to Health Authority queries, in coordination with Local RA Managers, CMC, and Roll-out teams
• Prepare, review, and obtain documentation for variation packages (labeling, administrative, clinical, and non-clinical) for assigned products, ensuring timely delivery to partners, market companies, and health authorities
• Monitor regulatory procedures through to final resolution, update regulatory databases with relevant information and documents, and communicate changes internally according to established procedures
• Track registration status of assigned products and maintain an up-to-date annual schedule of renewals and variations
• Supervise regulatory activities performed by consultants, CROs, local agents, and partners
• Contribute to the development and maintenance of policies and procedures governing regulatory operations with market companies and partners
• Provide regulatory expertise in cross-functional projects aligned with business strategy
• Request implementation of regulatory changes to packaging materials within established timelines
• Support Regulatory Strategy and Roll-out teams in resolving critical post-approval issues.

REQUIRED EDUCATION AND EXPERIENCE

• Bachelor's Degree in Life Sciences; advanced degree preferred
• Minimum 5 years of experience in Regulatory Affairs within international regions (EU, Turkey, Russia, CIS, MEA, LATAM, APAC)
• Strong knowledge of post-approval regulatory procedures, particularly in EU markets
• Hands-on experience managing EU registration procedures (CP/DCP/MRP), dossier preparation and submission, and interactions with regulatory authorities
• Fluent in English

PREFERRED SKILLS AND COMPETENCIES

• Excellent organizational and project management skills
• Ability to work independently and manage multiple priorities
• Strong attention to detail and commitment to regulatory compliance
• Effective communication and interpersonal skills
• Proficiency in regulatory systems and document management tools.
• Proven ability to build relationships and collaborate in a global team environment with key stakeholders
• Strong cross-functional collaboration skills, including with scientific disciplines.