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. /p pOur 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. /p pRecognised 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. /p pIf you care differently, you belong here. /p h3Position Summary / Mission /h3 pThe 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. /p h3Core Responsibilities /h3 ul liExecute 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 /li liPrepare, 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 /li liMonitor regulatory procedures through to final resolution, update regulatory databases with relevant information and documents, and communicate changes internally according to established procedures /li liTrack registration status of assigned products and maintain an up‑to‑date annual schedule of renewals and variations /li liSupervise regulatory activities performed by consultants, CROs, local agents, and partners /li liContribute to the development and maintenance of policies and procedures governing regulatory operations with market companies and partners /li liProvide regulatory expertise in cross‑functional projects aligned with business strategy /li liRequest implementation of regulatory changes to packaging materials within established timelines /li liSupport Regulatory Strategy and Roll‑out teams in resolving critical post‑approval issues /li /ul h3Required Education And Experience /h3 ul liBachelor’s Degree in Life Sciences; advanced degree preferred /li liMinimum 5 years of experience in Regulatory Affairs within international regions (EU, Turkey, Russia, CIS, MEA, LATAM, APAC) /li liStrong knowledge of post‑approval regulatory procedures, particularly in EU markets /li liHands‑on experience managing EU registration procedures (CP/DCP/MRP), dossier preparation and submission, and interactions with regulatory authorities /li liFluent in English /li /ul h3Preferred Skills And Competencies /h3 ul liExcellent organizational and project management skills /li liAbility to work independently and manage multiple priorities /li liStrong attention to detail and commitment to regulatory compliance /li liEffective communication and interpersonal skills /li liProficiency in regulatory systems and document management tools /li liProven ability to build relationships and collaborate in a global team environment with key stakeholders /li liStrong cross‑functional collaboration skills, including with scientific disciplines /li /ul /p #J-18808-Ljbffr
