Descripción de la oferta
We’re building the future of medical dermatology by focusing on unmet patient needs and giving people the space to think independently, take ownership and make an impact that matters.
Our purpose is simple: to transform patients’ lives by addressing real needs. We work with care, act with courage, keep things simple and focus our innovation where it makes a difference.
Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we continue to invest in an environment where people can grow and move forward.
If you care differently, you belong here.
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
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