Global Regulatory Affairs AssociateÈ il candidato/la candidata ideale per questa possibilità? Lo scopra leggendo la panoramica del ruolo qui sotto.We make it GmbH is a company operating nationally in Switzerland. Thanks to many years of successful experience, it has a high level of competence in the personnel services sector. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion.For our customer, the company CSL Seqirus, are we searching for:DescriptionCSL Seqirus is one of the world’s largest influenza vaccine companies, specializing in the development and manufacture of vaccines to help prevent influenza. The company uses both egg-based and cell-based technologies and has extensive research and production expertise. Its manufacturing facilities are located in the United States, the United Kingdom and Australia. CSL Seqirus is also a global leader in influenza prevention and a key partner in pandemic preparedness. Every year, its influenza vaccines help protect millions of people from seasonal influenza.Work hoursStandard 41h / WeekDuration6 MonthsTasksLead and execute regulatory strategies for assigned products and projectsPrepare, compile, and submit highquality regulatory applications,



including variations, renewals, and responses to health authority questionsEnsure regulatory dossiers remain compliant and up to date for EU, UK, and Switzerland marketsProvide regional regulatory expertise to support global development, CMC, compliance, and labeling activitiesLiaise with regulatory authorities and support regulatory agency interactionsCollaborate with cross-functional stakeholders including Regulatory Affairs, Quality, Medical, Pharmacovigilance, Commercial Operations, and Business Development teamsQualificationsDegree in Biological Sciences, Pharmacy, Allied Medical Discipline, or related field (advanced degree preferred) xysqume Minimum 5+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industryStrong experience with regulatory submissions and registrations in the EU, UK, and SwitzerlandExperience managing regulatory applications, variations, renewals, and health authority interactionsExposure to Veeva and regulatory application management systems is highly desirableExperience in vaccines and/or biologics is advantageousStrong project management, stakeholder management, and communication skillsEnglish proficiency is required as all Seqirus business is conducted in English#J-18808-Ljbffr

📌 Global Regulatory Affairs Associate (M/W/D) For Csl Seqirus (Siena)
🏢 We make it
📍 Siena