Regulatory Affairs Associate (d/f/m) in Zug

h3Job Description Summary /h3pSee Job Description. Job Description Workplace: Rotkreuz, Switzerland until 31 December 2027; Basel, Switzerland as of 01 January 2028. Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. /ppAs we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. /ppJoin us, the future is ours to shape! /ph3Your Key Responsibilities /h3ulliGuarantees adherence to the relevant (local) procedures, and record management. /liliSupports RA during internal and external audits and health authority inspections at country level. /liliSupports in the timely creation translation of official product information including Patient Information Leaflets, Summary of Product Characteristics (SmPCs) and all labelling (packaging texts into artworks). /liliSupports in the maintenance of registration files. /liliSupports administrative activities. /liliRegistration maintenance activities, product related text translations (checks). /liliAnswering questions from local health authorities regarding registered products. /liliArtwork management from change to approved new/revised artwork. /liliUpdating regulatory databases and plans. /liliLocal regulatory tasks related to Risk Management Plan (RMP) / Risk Minimization Activities (RMA) and Dear Healthcare Professional Communications (DHPC) (as per global SOP). /liliSupports in timely preparing the payment of regulatory fees and related administrative activities. /liliSupports RA database maintenance activities, timely KPI preparation and reporting. /liliCan be responsible for creation and follow-up of purchase orders, proof-of-payments, and other RA fees for the RA team. /liliArchiving of RA related documentation (paper and/or electronic archive maintenance). /liliGuarantee good and professional communication between internal and external stakeholders. /liliSupport (local) RA projects. /liliParticipates in Product Cross Functional Teams as required. /liliProvide close regulatory support to internal local stakeholders, as well as other Global Regulatory Teams. /liliCheck Swissmedic updates and follow trends in the regulatory environment and legislation, assure awareness and alignment within the department, to meet future requirements on time. /liliSupport signal notification to Swissmedic. /liliSupport Pharmacovigilance activities. /li /ulh3Essential and Desirable Requirements /h3ulliEither a bachelor in Bio-Medical / Life Sciences / Pharmaceutical sciences or a professional administrative degree. /liliPreferably 1 year of relevant work experience. /liliGerman (fluent: verbal and written), English (fluent: verbal and written) French (desirable) and Italian (desirable). /liliExperience of working in a highly regulated environment. /liliPlanning, organizational skills and eye for detail. /liliStrong administrative organization skills. /liliStrong written communication skills. /liliData management and IT skills (MS Office package / SAP). /li /ulh3Why Sandoz? /h3pSandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! /ppWhile we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health. With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably. /ppOur momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! /ppJoin us, help us make healthcare fairer and faster. /ph3Commitment to Diversity Inclusion /h3pWe are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. /ph3Accessibility and accommodation /h3pSandoz is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, please send an e‑mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message. /pp#Sandoz Skills Desired Data Analysis, Documentation Management, Operational Excellence /ph3Our Purpose /h3pHere at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! /ppPowered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative inclusive culture where diversity of thought is welcomed and where personal growth is nurtured! /p #J-18808-Ljbffr