ph3The Position /h3 pCoordinating 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. /p h3Job Description /h3 pCoordinating 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. /p h3Responsibilities /h3 ul liEnsure 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. /li liCoordinate, manage, and support regulatory activities across Europe, including EEA, Switzerland, the United Kingdom, and non-EU EEI countries, as needed. /li liOversee 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. /li liDevelop and implement regulatory strategies for registered products, development projects, and new marketing authorization applications. /li liStay updated on relevant EU regulations and guidelines to provide expert regulatory advice. /li liRepresent European Regulatory Affairs on assigned non-product related projects. /li liBuild and maintain strong relationships with internal and external stakeholders across regulatory and cross-functional teams. /li liProvide support for regulatory activities in non-European countries as needed. /li liEnsure 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. /li liMaintain 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 /li liReview and confirm variation classifications while supporting complex regulatory submissions. /li liPrepare supportive administrative documents and review submissions where required /li liFor labelling variations, coordinate labelling requests with the Labelling Team and prepare the necessary product information. /li liOversee the authoring and timely submission of response documents to Health Authority queries. /li liEnsure regulatory milestones for assigned projects are achieved and effectively communicated to stakeholders. /li liProvide regulatory input and expertise during internal functional and cross-functional governance meetings, as required. /li liAct as the local or regional Regulatory Affairs representative on assigned cross-functional teams for non-product-related initiatives. /li liDevelop and implement efficient processes to meet business objectives while ensuring compliance with regulatory requirements. /li liUnderstand downstream impact of regulatory changes to local country functions. /li liMaintain strong scientific knowledge and expertise in all assigned product areas, staying updated on regulatory changes that may influence company strategy. /li liAdhere to company leadership principles and compliance standards in all daily activities. Build and sustain effective working relationships with relevant regulatory authorities. /li liCollaborate as a committed member of the European Regulatory Affairs team, contributing to both functional and cross-functional projects. /li /ul h3Required Education, Experience And Skills /h3 h3Education / Certificates /h3 pUniversity graduate in life sciences, preferably pharmacy/pharmacology. /p h3Skills /h3 ul liFluency in written and spoken English is essential, with proficiency in at least one additional European language being highly desirable. /li liProficient 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. /li /ul h3Competencies /h3 ul liStrong verbal and written communication skills are essential, with excellent organizational and planning abilities. /li liDemonstrates meticulous attention to detail and adaptability to manage conflicting deadlines and high workloads effectively. /li liExhibits a mature and professional approach to work, with a clear understanding of the commercial significance of the role.



/li liProven ability to collaborate with colleagues across all levels and functions, both within Europe and internationally, with potential to take on leadership responsibilities. /li liCapable of working independently and as part of a team across a wide geographic scope. /li /ul h3Experience /h3 ul liA 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. /li liAdequate subject matter knowledge to operate with minimal oversight from the Manager. /li /ul pAt Organon Spain we have a current local Equity Plan that ensures equal treatment and opportunities for all our employees and candidates. /p h3Secondary Job Description /h3 pOrganon 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. /p pAs 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. /p h3Search Firm Representatives Please Read Carefully /h3 pOrganon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. /p h3Annualized Salary Range /h3 h3Annualized Salary Range (Integral) /h3 h3Annualized Salary Range (Canada) /h3 h3Please Note: Pay ranges are specific to local market and therefore vary from country to country. /h3 h3Employee Status /h3 pRegular /p h3Relocation /h3 pNo relocation /p h3VISA Sponsorship /h3 h3Travel Requirements /h3 pOrganon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites /p h3Flexible Work Arrangements /h3 pHybrid, Remote Work /p h3Shift /h3 h3Valid Driving License /h3 h3Hazardous Material(s) /h3 h3Number of Openings /h3 p1 /p pRequisition ID: R /p /p #J-18808-Ljbffr

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