Regulatory Affairs Jobs in Kufstein
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Novartis Farmacéutica-Kufstein
Regulatory Affairs Medical Device Manager (Schaftenau, Austria)
Job ID REQ-10011610
Sep 02, 2024
Austria
Summary
Our Development Team is guided by our purpose: to reimagine medicineto improve and extend people’s lives.
To do this, we are...
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Novartis-Langkampfen, 10 km von Kufstein
Apply today and welcome to where we thrive together!
About the Role
Major accountabilities:
• Formulate, lead and drive global CMC regulatory strategy for Biologics or Small Molecules projects/products drawing on substantial regulatory expertise with...
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Novartis Farmacéutica-Kufstein
therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster.
As senior manager, you independently provide strategic and operational global CMC regulatory direction and documentation for our products covering...
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Sandoz-Kundl, 21 km von Kufstein
submission strategy for EU and interact with Health Authority as needed
• Serve as a strategic partner for internal stakeholders from regulatory affairs, pharmacovigilance, medical, country organizations, and other relevant functions
• Provide labeling...
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Novartis Farmacéutica-Kufstein
Regulatory Affairs CMC Associate Director
Job ID REQ-10011560
Sep 02, 2024
Austria
Summary
Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives.
To do this, we are optimizing...
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Novartis-Langkampfen, 10 km von Kufstein
Bestimmungen in hoher Qualität erfolgt.
• Sicherstellen, dass die Komponenten in der erforderlichen Qualität für klinische Versuche und die kommerzielle Produktion geliefert und kontrolliert werden.
• Unterstützung der Abteilung Regulatory Affairs...
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Novartis Farmacéutica-Kufstein
in chemistry, biology, pharmacy, biotechnology or equivalent.
• More than 3 years of experience in an operational GxP area, in Manufacturing, Development or QA or Regulatory Affairs; with a thorough knowledge of biologic drug product manufacturing processes...
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Healthcare Businesswomen’s Association-Kufstein
production.
• Support Regulatory Affairs to prepare medical device/combination product pre-registration documents and provides input to answer health authority questions.
• Support internal & external audits on medical devices related matters and provide...
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Healthcare Businesswomen’s Association-Kundl, 21 km von Kufstein
and submission of regulatory dossiers, maintenance of regulatory databases and archives and artwork-related activities.
What you’ll bring to the role:
1. Completed degree high school diploma.
2. 2 years of experience within Regulatory Affairs for Biosimilars.
3. ..
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Healthcare Businesswomen’s Association-Kundl, 21 km von Kufstein
as needed
• Serve as a strategic partner for internal stakeholders from regulatory affairs, pharmacovigilance, medical, country organizations, and other relevant functions
• Provide labeling input for aggregate reports, Risk Management Plans (RMPs...
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