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Chemist, Pharmacist, Biologist, Biotechnologist as Regulatory CMC Manager - Biosimilars (m/f)

Regulatory CMC Manager Biosimilars (m/f) Regulatory Affairs Biopharmaceuticals, Sandoz GmbH, Kundl

Area of Responsibility

  • Regulatory CMC input in and support of development projects of biopharmaceutical products
  • Preparation, coordination and compilation of quality parts of regulatory dossiers for worldwide submissions of biopharmaceutical products, ensuring that regulatory CMC requirements are met
  • Write high-quality CMC documentation during development and product registration, but also for already marketed products, respecting agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines
  • Close monitoring of regulatory requirements issued by the authorities and evaluation of their relevance for our dossiers
  • Continuous update of and maintenance of the dossiers according to new requirements, requests received from authorities and deriving from technical changes
  • Prepare CMC responses to health authority questions during development, registration, and product lifecycle

Qualifications

  • Education: University degree (PhD or alternatively Master with min 4 years relevant professional experience) in Chemistry, Pharmacy, Biology, Biotechnology or a similar education, further education in Regulatory Affairs desirable
  • Languages: English (fluent) / German (basics)
  • Experience: Working experience in the pharmaceutical industry , ideally with quality parts of registration documentsdesirable
Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, childcare facility, training possibilities and global career opportunities). In accordance with the Austrian collective labour agreement, we advise you that the minimum gross annual salary for this role is 45.780,- euros.
Contact: Marlene Hengster, Junior HR Manager
Job-ID: 174605BR
Sandoz is an equal opportunity employer
While applying for the job please refer to jobvector and use the following reference number: 174605BR

About Sandoz GmbH

Sandoz ist eines der größten Pharmaunternehmen Österreichs mit über 4000 Mitarbeitern. Als Teil der weltweiten Novartis Gruppe entwickeln, fertigen und vermarkten wir patentfreie Arzneimittel vor allem Antibiotika, injizierbare Krebsmedikamente und innovative Biosimilars. Mit unseren Arzneimitteln verbessern wir die Lebensqualität von Patienten in aller Welt....

More about Sandoz GmbH

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