... management, and clinical trials.Lead regulatory submissions, including premarket approvals (PMAs), ... on the business.Participate in regulatory audits and inspections, and drive ... 8 years of experience in regulatory affairs within the medical device ...
... Principles (GAAP), US Regulatory, and local statutory reporting, in ... Budapest supporting local German regulatory group.Ensure overall reporting efficiency, ... depth knowledge of German regulatory reportingGood communication and analytical skillsExcellent ...
... prepare to minimize economic and regulatory challenges.Responsibilities:You will play ... understanding of recent or pending regulatory initiatives, e.g. RRD, CRR ... the ability to convey complex regulatory matters in easy-to-understand ...
... tasks as Junior Regulatory Affairs Manager CMC be? Production ... implementation of regulatory strategies as well as the coordination of regulatory processes and projectsPreparation of submissions ... position of Junior Regulatory Affairs Manager CMC offer you? ...
... sowie die Umsetzung der globalen Regulatory Affairs Strategien und -Anforderungen. Darüber ... ProdukterhaltungUnterstützung beim Aufbau eines konzernweiten Regulatory Affairs NetzwerksLeitung und Umsetzung des ...
... requirements in the overarching global regulatory strategy, and develop risk assessment ... prior relevant experience in pharmaceutical Regulatory Affairs and regulatory procedures (including CP DCP MRP). ...
... accountable for the global regulatory CMC strategy as well as ... Authority interactions meetings as regulatory CMC lead and will perform regulatory CMC expert assessments of in- ... registration Experience in driving regulatory CMC activities and in authoring ...
... region. • Lead the respective regional regulatory sub-team.• Drive the regulatory submission in your respective region. ... ensure ongoing compliance. Partner with Regulatory Project Management and Submission Management.• ...
... European Union product safety, regulatory and liability requirements. Support research and review of global regulatory requirements. Protect Company assets from ... associated function and activities, regulatory systems, and processesWork independently and ...
... of product registrations within International Regulatory AffairsMajor ResponsibilitiesCompile and follow-up ... with IVDR Program contacts and Regulatory Teams in China & JapanSupport impact ... Quality, Manufacturing, R&D, Regulatory or related areas.Min. 2- ...