Descripción de la oferta
ppWe’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. /p h3Summary/ Mission /h3 pThe Global Regulatory Affairs Senior Manager leads assigned post‑approval regulatory activities for Almirall’s global legacy products. The role defines regulatory strategies, 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. /p h3Tasks And Responsibilities /h3 ul liDefine 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 managers at Market Companies, Local consultants or partners and, where applicable, also with CMC and roll‑out regulatory responsible. /li liPrepare and/or review 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. /li liFollow up regulatory procedures up to final resolution, reporting on the regulatory databases all relevant information and associated documents. Inform the organization as per internal procedures to ensure implementation of regulatory changes. /li liMonitor the registration status of products under responsibility and keep annual schedule of renewals and variations updated with all regulatory procedures to be performed. /li liRequest implementation of the regulatory changes that affect packaging materials and participate in their approval. /li liLead activities carried out for regulatory purposes through consultants, CROs, local agents and partners. /li liSupport preparation and integration of the Department’s budget. /li liSupport 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 represent them in corporate projects. /li liProvide regulatory expertise and leadership in cross‑functional projects aligned with business strategy definition. /li /ul h3Education /h3 ul liBatchelor’s Degree in Life Sciences. Advanced degree preferred but not required. /li /ul h3Experience And Specific Knowledge /h3 ul liMinimum 8‑10 years of experience. /li liStrong 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. /li liHands‑on operational experience of managing EU registration procedures (CP/DCP/MRP), dossier preparation and submission, and regulatory authority interactions. /li liFluent English. /li liAbility to build team relationships and collaborate in a global team environment with key stakeholders across the organization. /li liAbility to effectively collaborate with various business functions as well as cooperate with some scientific disciplines. /li /ul /p #J-18808-Ljbffr
