h3Global Regulatory Affairs Associate /h3 pWe 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. /p pFor our customer, the company CSL Seqirus, are we searching for: /p h3Description /h3 pCSL 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. /p h3Work hours /h3 pStandard 41h / Week /p h3Duration /h3 p6 Months /p h3Tasks /h3 ul liLead and execute regulatory strategies for assigned products and projects /li liPrepare, compile, and submit highquality regulatory applications, including variations, renewals,



and responses to health authority questions /li liEnsure regulatory dossiers remain compliant and up to date for EU, UK, and Switzerland markets /li liProvide regional regulatory expertise to support global development, CMC, compliance, and labeling activities /li liLiaise with regulatory authorities and support regulatory agency interactions /li liCollaborate with cross-functional stakeholders including Regulatory Affairs, Quality, Medical, Pharmacovigilance, Commercial Operations, and Business Development teams /li /ul h3Qualifications /h3 ul liDegree in Biological Sciences, Pharmacy, Allied Medical Discipline, or related field (advanced degree preferred) /li liMinimum 5+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry /li liStrong experience with regulatory submissions and registrations in the EU, UK, and Switzerland /li liExperience managing regulatory applications, variations, renewals, and health authority interactions /li liExposure to Veeva and regulatory application management systems is highly desirable /liliExperience in vaccines and/or biologics is advantageous /li liStrong project management, stakeholder management, and communication skills /li liEnglish proficiency is required as all Seqirus business is conducted in English /li /ul #J-18808-Ljbffr

📌 Global Regulatory Affairs Associate (m/w/d) for CSL Seqirus (Siena)
🏢 We make it
📍 Siena