ph3Job Description /h3h3The Position /h3pCoordinating and supporting all regulatory activities to maintain registrations and to obtain new marketing authorizations for the company portfolio/pipeline subject to EU procedures (Centralized, Mutual Recognition, Decentralized, National authorized Procedures) across therapeutic areas. The position also requires strong project management skills to oversee regulatory initiatives, manage timelines effectively, and facilitate collaboration within cross-functional teams. /ph3Responsibilities /h3ulliEnsure the maintenance of marketing authorizations across Europe for assigned products by preparing and submitting post-approval applications in a timely manner, in collaboration with the GRL and European country affiliates. /liliCoordinate, manage, and support regulatory activities across Europe, including EEA, Switzerland, the United Kingdom, and non-EU EEI countries, as needed. /liliOversee the preparation and review of regulatory documentation to align with corporate objectives, maintaining interactions with relevant EU regulatory Agencies, EMA and Country Regulatory Affairs teams. /liliDevelop and implement regulatory strategies for registered products, development projects, and new marketing authorization applications. /liliStay updated on relevant EU regulations and guidelines to provide expert regulatory advice. /liliRepresent European Regulatory Affairs on assigned non-product related projects. /liliBuild and maintain strong relationships with internal and external stakeholders across regulatory and cross-functional teams. /liliProvide support for regulatory activities in non-European countries as needed. /liliEnsure the timely preparation and submission of appropriate documentation for new Marketing Authorization Applications through CP, MRP, DCP, working closely with cross-functional teams at regional and integral levels,



and country affiliates as needed. /liliMaintain compliance of marketing authorizations with regulatory requirements by performing lifecycle management activities, including but not limited to preparation and submission, with a high standard of quality and within agreed timelines, supporting country affiliates where necessary. Supports complex submissions like groupings, super-grouping and work-sharing for CP/MRP/DCP/ NAPs and mixed procedures. /liliReview and confirm variation classifications while supporting complex regulatory submissions. /liliPrepare supportive administrative documents and review submissions where required. /liliFor labelling variations, coordinate labelling requests with the Labelling Team and prepare the necessary product information. /liliOversee the authoring and timely submission of response documents to Health Authority queries. /liliEnsure regulatory milestones for assigned projects are achieved and effectively communicated to stakeholders. /liliProvide regulatory input and expertise during internal functional and cross-functional governance meetings, as required. /liliAct as the local or regional Regulatory Affairs representative on assigned cross-functional teams for non-product-related initiatives. /liliDevelop and implement efficient processes to meet business objectives while ensuring compliance with regulatory requirements. /liliUnderstand downstream impact of regulatory changes to local country functions.



/liliMaintain strong scientific knowledge and expertise in all assigned product areas, staying updated on regulatory changes that may influence company strategy. /liliAdhere to company leadership principles and compliance standards in all daily activities. Build and sustain effective working relationships with relevant regulatory authorities. /liliCollaborate as a committed member of the European Regulatory Affairs team, contributing to both functional and cross-functional projects. /li /ulh3Required Education, Experience, and Skills /h3h3Education / Certificates /h3pUniversity graduate in life sciences, preferably pharmacy/pharmacology. /ph3Skills (professional and/or technical) /h3pFluency in written and spoken English is essential, with proficiency in at least one additional European language being highly desirable. Proficient in using regulatory information management systems and tools, including Veeva, Ennov, Power BI, as well as standard office applications such as word processing, spreadsheets, database software, and internet-based tools. /ph3Competencies /h3pStrong verbal and written communication skills are essential, along with excellent organizational and planning abilities. /ppDemonstrates meticulous attention to detail and adaptability to manage conflicting deadlines and high workloads effectively. /ppExhibits a mature and professional approach to work, with a clear understanding of the commercial significance of the role. /ppProven ability to collaborate with colleagues across all levels and functions, both within Europe and internationally, with potential to take on leadership responsibilities. /ppCapable of working independently and as part of a team across a wide geographic scope. /ph3Experience /h3pA minimum of 5 years of experience in the pharmaceutical industry or a c /p /p #J-18808-Ljbffr

📌 Senior Specialist Regulatory Affairs, European Union Countries (España)
🏢 PVH (Tommy Hilfiger/Calvin Klein)
📍 España