PpFounded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica's mission is to continuously strive to improve therapies by enhancing its products' formulations and usability for the benefit of clinicians and patients. /p pWe do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer for patients and easier to perform. Every year we reliably supply millions of doses of our products across a range of therapeutic classes, including anaesthesia and analgesia, while expanding to address further healthcare needs. /p pTo strengthen our Regulatory Affairs department at our headquarter in Mendrisio (Switzerland), we are currently looking for a bRegulatory Affairs Specialist /b. /p h3Position Summary /h3 pWe are seeking a Regulatory Affairs Specialist to support regulatory compliance and contribute to the submission and maintenance of national and international authorizations. The role will operate under the guidance of a supervisor and will involve collaboration with cross‑functional teams to ensure timely and accurate regulatory deliverables. /p h3Key Responsibilities /h3 ul liSupport the preparation, submission, and maintenance of medicinal product registrations across global markets (EU, Switzerland, and Rest of World). /li liIndependently and critically prepare and/or review regulatory documentation for marketing authorization applications (MAAs), variations, renewals, and other regulatory activities. /li liCoordinate with internal departments, local partners, Marketing Authorization Holders (MAHs), and external consultants to ensure high‑quality submissions. /li liReview product labeling to ensure compliance with applicable global regulatory requirements. /li liMaintain registration documentation in alignment with the latest regulatory guidelines and health authority expectations. /li /ul h3Qualifications And Skills /h3 ul liMaster’s degree in a scientific discipline (Pharmaceutical Sciences, Chemistry, Biology, or related field). /li liMinimum of 4–5 years of experience in Regulatory Affairs within the pharmaceutical industry focused on finished medicinal products (small molecules). /li liSolid understanding of pharmaceutical legislation and regulatory frameworks. /li liProven experience with EU registration procedures (MRP/DCP MAAs, variations, extensions, and renewals). /li liPrevious experience with non‑EU registrations is an advantage. /li liStrong organizational and planning skills. /li liAbility to interpret and effectively communicate regulatory requirements. /li liProactive, detail-oriented, and capable of working independently. /li liStrong interpersonal and team collaboration skills; able to manage deadlines effectively. /li liProficient written and verbal communication skills in English. /li liKnowledge of French and/or German is considered a plus. /li liHigh attention to detail and a commitment to quality. /li liPrevious experience with finished pharmaceutical medicinal products is mandatory. Applications limited to experience in medical devices, food supplements, cosmetics, or APIs will not be prioritized. /li /ul pPreference will be given to candidates of Swiss nationality and residents (Permit B -C). /p h3We offer /h3 ul liFulltime permanent employment in a young working environment and positive culture. /li liSintetica promotes diversity and gender equality. /li /ul /p #J-18808-Ljbffr