Regional Regulatory Affairs Manager (m/f/d) EU/UK/CH

YOUR CONTRIBUTIONAs a Regional Regulatory Affairs Manager (m/f/d), you will provide regional regulatory support for the strategic development, approval, and life cycle management of drugs, ensuring compliance with regulatory and legal requirements in the region EU/UK/CH. This will include the following activities:Dossier Preparation: Develop and maintain high-quality regulatory documentation for EU/UK/CH region, ensuring compliance with internal and international standardsMarketing Authorization: Coordinate and submit applications for new registrations, approvals, and GMP verifications, adhering to national regulatory requirementsChange Control & Product Information: Implement local regulatory changes and update product information texts and packaging in line with company and national standardsLife-Cycle Management: Manage regulatory life-cycle activities, including renewals, variations, and post-approval commitments, in collaboration with internal and local teamsResponse Management: Handle deficiency letters from regulatory authorities, ensuring timely and accurate responsesProject Coordination: Communicate regional regulatory needs to global teams, coordinate with local partners, and manage third-party service providersRegulatory Strategy & Intelligence: Contribute to regulatory strategies and stay updated on regional regulatory requirements and best practicesAgency Interactions: Prepare for and participate in meetings with regulatory authorities, collaborating with local and global stakeholdersYOUR PROFILECompleted scientific Studies in Pharmacy, Biology, Chemistry or a related field of studies, a doctorate is an advantage3-5 years of professional experience dealing with regulatory affairs aspects in the region EU/UK/CH and specifically the centralized procedure within the pharmaceutical industryStrong communication skills, also intercultural, including profound English (at least business fluent)Strong problem-solving skills and analytical thinking abilityTeam Player with persistenceYOUR BENEFITSIndividual career development in a purposeful job: you improve the quality of life of our patients!Hybrid work model that allows a good work-life balanceAttractive location with good transport links, modern workplaces and a company restaurantGlobal family business with flat hierarchies and an open, respectful corporate cultureAttractive remuneration with extensive social benefitsVariety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBikeFind our more about our benefits here.ABOUT USWelcome to Merz Therapeutics, a leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases and other health conditions regain their quality of life.We are proud to be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.Our goal is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.Our dedication and commitment to relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal: "BETTER OUTCOMES FOR MORE PATIENTS"For more information, visit .More infoFull TimeAlfred-Wegener-Straße 2, 60438 Frankfurt am Main, DeutschlandWith Professional Experience8/3/26