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Holzkirchen - Head Regulatory Life Cycle Managment

Pharmazeutische Industrie - Produktion, Herstellung - Senior Fachkraft / Projektleiter

Job Description • Accountability for leading Sandoz regulatory units responsible for product maintenance to secure product compliance in line with business objectives, and in cooperation with key internal and external stakeholders. • Accountable for timely regulatory lifecycle management of files in target geographies in accordance with local requirements and standards set by Sandoz. • Compile and submit updates to registration dossiers which adequately prove quality, safety and efficacy, for submission to the Health Authorities (in close cooperation with other stakeholders). • Follow-up on questions asked by Health Authorities, in order to obtain approval to amendments/variations. • Protec ...

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