ph3Job Description /h3pThe Position Coordinating 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 global 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. /liliSupports complex submissions like groupings, super-grouping and work-sharing for CP/MRP/DCP/ NAPs and mixed procedures Review 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. /liliBuild 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, with excellent organizational and planning abilities. Demonstrates meticulous attention to detail and adaptability to manage conflicting deadlines and high workloads effectively. Exhibits a mature and professional approach to work, with a clear understanding of the commercial significance of the role. Proven ability to collaborate with colleagues across all levels and functions, both within Europe and internationally, with potential to take on leadership responsibilities.



Capable 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 comparable field, with extensive involvement in registration processes across multiple European markets and practical expertise in managing European regulatory procedures. Adequate subject matter knowledge to operate with minimal oversight from the Manager. /ppAt Organon Spain we have a current local Equity Plan that ensures equal treatment and opportunities for all our employees and candidates. /ph3Secondary Job Description /h3h3Who We Are: /h3pOrganon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman. As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. /ph3Annualized Salary Range /h3pPlease Note: Pay ranges are specific to local market and therefore vary from country to country. /ppEmployee Status: Regular Relocation: No relocation VISA Sponsorship: Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites Adaptable Work Arrangements: Hybrid, Remote Work Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1 /ppAt Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments. /p /p #J-18808-Ljbffr

📌 Senior Specialist Regulatory Affairs, European Union Countries (Madrid)
🏢 Organon
📍 Madrid