REGULATORY AFFAIRS SENIOR MANAGER

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. Summary/ Mission The Global Regulatory Affairs Senior Manager leads assigned post‑approval regulatory activities for Almirall’s global legacy products. The role defines regulatory strategies, and ensures timely and compliant submissions in coordination with market companies, partners, consultants, and cross‑functional teams. It ensures accurate product registration status, drives regulatory implementation across the organization, and represents Regulatory Affairs in internal and external meetings. Tasks And Responsabilities Define the strategy, regulatory procedure and oversight of timelines and requirements for assigned product(s) in lifecycle maintenance for markets in the international region through liaison with Local RA (Regulatory Affairs) managers at Market Companies, Local consultants or partners and when applicable also with CMC and roll-out regulatory responsible. Prepare and/or review of variation packages for labelling, administrative, clinical and non-clinical changes for assigned product(s) lifecycle maintenance for markets in the international region ensuring they are delivered to partners, market companies and health authorities within the established deadlines. Follow up regulatory procedures up to final resolution, reporting on the regulatory databases all relevant information and associated documents. Also, inform the organization as per internal procedures to ensure implementation of regulatory changes. Monitor the registration status of products under responsibility and keep annual schedule of Renewals and Variations updated with all regulatory procedures to be performed. Request the implementation of the regulatory changes that affect the packaging materials and participate in their approval. Leads activities carried out for regulatory purposes through consultants, CROs (Contract Research Organizations), local agents and partners. Supports in the preparation and integration of the Department’s budget. Support to market companies for products that may need it, for planning regulatory procedures, when there is a lack or extra need for occasional regulatory support and representing them in corporate projects. Provide regulatory expertise and leadership in cross-functional projects aligned with business strategy definition. Education Batchelor’s Degree in Life Sciences. Advanced degree preferred but not required. Experience And Specific Knowledge Minimum 8-10 years of experience Strong knowledge of post-approval regulatory procedures in the international markets, particularly in the EU markets. Familiarity with drug development and pre-approval procedures is a plus. Hands on operational experience of managing EU registration procedures (CP/DCP/MRP), dossier preparation and submission, and Regulatory authority interactions. Fluent English. Ability to build team relationships and collaborate in a global team environment with key stakeholders across the organization. Ability to effectively collaborate with various business functions as well as cooperate with some scientific disciplines. For more than 80 years, we have combined science and purpose to advance medical dermatology—turning research into solutions that improve patients’ lives. Uncommon by Nature is who we are. A way of thinking and working that prioritises relevance over size, combines long‑term ambition with the drive to deliver impact now, and challenges what’s expected to raise standards in medical dermatology. Almirall is at a pivotal moment, shaped by clear strategic direction, bold scientific ambition and the capabilities to redefine what’s possible in medical dermatology. Joining now means becoming part of a company that has placed R&D at its core from day one. As the only fully integrated pharmaceutical company in the Western Hemisphere dedicated exclusively to medical dermatology, we cover the full value chain — from discovery and development to manufacturing and commercialization. Let’s shape what comes next. You’re close to the impact. Patients aren’t a distant idea here. You can actually get things done. Less distance between an idea and a decision. You’re trusted to own it. Responsibility is real, not symbolic. You grow by doing. Big ambition, steady progress, room to stretch. You don’t just choose a job here. You choose how you’ll make an impact. Global reach, local impact. Scale and proximity don’t have to be opposites. In Almirall, they fuel each other. 2,000 professionals across 100 countries. 19 affiliates worldwide. A fully integrated value chain, from research to patients.