Senior Specialist Regulatory Affairs, European Union Countries

Job description

Job Description The 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. Responsibilities Ensure 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. Coordinate, manage, and support regulatory activities across Europe, including EEA, Switzerland, the United Kingdom, and non-EU EEI countries, as needed. Oversee 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. Develop and implement regulatory strategies for registered products, development projects, and new marketing authorization applications. Stay updated on relevant EU regulations and guidelines to provide expert regulatory advice. Represent European Regulatory Affairs on assigned non-product related projects. Build and maintain strong relationships with internal and external stakeholders across regulatory and cross-functional teams. Provide support for regulatory activities in non-European countries as needed. Ensure 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. Maintain 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 Review and confirm variation classifications while supporting complex regulatory submissions. Prepare supportive administrative documents and review submissions where required For labelling variations, coordinate labelling requests with the Labelling Team and prepare the necessary product information. Oversee the authoring and timely submission of response documents to Health Authority queries. Ensure regulatory milestones for assigned projects are achieved and effectively communicated to stakeholders. Provide regulatory input and expertise during internal functional and cross-functional governance meetings, as required. Act as the local or regional Regulatory Affairs representative on assigned cross-functional teams for non-product-related initiatives. Develop and implement efficient processes to meet business objectives while ensuring compliance with regulatory requirements. Understand downstream impact of regulatory changes to local country functions. Maintain strong scientific knowledge and expertise in all assigned product areas, staying updated on regulatory changes that may influence company strategy. Adhere to company leadership principles and compliance standards in all daily activities. Build and sustain effective working relationships with relevant regulatory authorities. Collaborate as a committed member of the European Regulatory Affairs team, contributing to both functional and cross-functional projects. Required Education, Experience, and Skills Education / Certificates University graduate in life sciences, preferably pharmacy/pharmacology. Skills (professional and/or technical) Fluency 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. Competencies Strong verbal and written communication skills are essential, along 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. Experience A 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. At Organon Spain we have a current local Equity Plan that ensures equal treatment and opportunities for all our employees and candidates. Secondary Job Description Who We Are: Organon 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. Search Firm Representatives Please Read Carefully Organon 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. Annualized Salary Range Annualized Salary Range (Global) Annualized Salary Range (Canada) Please Note: Pay ranges are specific to local market and therefore vary from country to country. Employee 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 Flexible Work Arrangements: Hybrid, Remote Work Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1