Suchergebnisse: 18 Stellenangebote
60.212,18€ pro Jahr
...Sandoz GmbH das Richtige für dich sein!
Zur Verstärkung des Teams suchen wir ab sofort in Kundl im Tiroler Unterland eine/n:
Regulatory Affairs Manager (m/w/d) - Regulierungsysteme / Compliance
Das Aufgabengebiet umfasst folgende Tätigkeiten:
Leitung und...
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...Sandoz GmbH das Richtige für dich sein!
Zur Verstärkung der Teams suchen wir ab sofort in Kundl im Tiroler Unterland eine/n:
Regulatory Affairs Manager (m/w/d)
Das Aufgabengebiet umfasst folgende Tätigkeiten:
Verantwortung für die Zulassung neuer medizinischer...
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60.212,18€ pro Jahr
...About the role
Regulatory Affairs Manager (m/f/d), Sandoz, Kundl, Austria
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed...
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PhD Position
Teilzeitarbeit
Homeoffice
60.212,18€ pro Jahr
About the Role
Authority Affairs Manager (m/w/d), Kundl, Tirol, Österreich
Die Position:
Als Authority Affairs Manager sind Sie verantwortlich für die Schnittstelle zwischen Novartis und den Behörden der Bezirkshauptmannschaft, des Landes Tirol, des Arbeitsinspektorates...
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Weltweit
60.212,18€ pro Jahr
...professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!
1500! This is the average number of new submission Regulatory Affairs (Sandoz Small Molecule) does per year.
Global – this is the name of the market for which the registration manager will be...
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Teilzeitarbeit
Homeoffice
60.600€ pro Jahr
...that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures.
About the...
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Teilzeitarbeit
Homeoffice
60.212,18€ pro Jahr
...Support of fundamental GMP processes.
• Preparation of production supporting documents and concepts, as well as for internal and regulatory inspections.
• Ensure real time shop floor support as an expert on technical problems and ensuring the completion of all...
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Teilzeitarbeit
Homeoffice
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Reisebereitschaft(31)
SAP(41)
Homeoffice(93)
Einschulung(100)
Schichtarbeit(71)
Flexible Arbeitszeit(140)
Weiterbildung(209)
Lehre(98)
Mit Führerschein(156)
60.212,18€ pro Jahr
...control and fundamental understanding of applied statistics (MS-office, PI, Minitab, JMP)
• Understanding and oversight of relevant regulatory requirements, e.g. GMPs, ICH Q guidelines.
• Fluent in English and proficient in German
• Ability to act in a sophisticated...
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Teilzeitarbeit
Homeoffice
...HTL im Bereich Mechatronik, Maschinenbau, Mechaniker, etc.
Erste Berufserfahrung im Projektmanagement oder im Bereich der Regulatory Affairs wünschenswert
Gute Deutsch- und Englischkenntnisse
Bereitschaft zur Schichtarbeit
Deine Vorteile:
Verschiedene Aus...
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Lehre
Schichtarbeit
60.212,18€ pro Jahr
...chromatographic, various modes).
• Understanding of development activities and processes in Biopharma and knowledge on relevant regulatory guidelines.
• Basic programming skills (e.g. R, Phyton) and a general ability to quickly adapt to new data and digital...
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43.548,4€ pro Jahr
...-Adherence to good documentation practice and data integrity regulations
-Preparation for and participation in inspections (regulatory authorities, customers, Sandoz/Novartis, safety)
-Updates and maintains relevant information in electronic systems (e.g. documentation...
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Teilzeitarbeit
Homeoffice
60.212,18€ pro Jahr
...Experience with Sterile manufacturing.
- Thorough knowledge of cGMP requirements.
- Thorough knowledge of cGMP, ICH guidelines, regulatory requirements & risk management.
- Good leadership skills and experiences in leading project teams
- Strong track record in...
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Teilzeitarbeit
Homeoffice
80.433,64€ pro Jahr
...compliance with quality, Health, Safety and Environment (HSE), Good Manufacturing Practices (GMP), customer service, statutory, regulatory and Novartis requirements
• Contribute to the achievement of the objectives by manufacturing and supplying products of high quality...
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Teilzeitarbeit
Homeoffice
66.800€ pro Jahr
...to internal/external manufacturing sites.
Writing and reviewing of high-quality reports for submissions preparation, review of regulatory CMC documents and contribution to interactions with health authorities and audits as subject matter expert
Drive and support...
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PhD Position
Teilzeitarbeit
Homeoffice
73.112,9€ pro Jahr
...improve efficiency and output within the boundaries of aseptic manufacturing.
• Ensuring all the systems are in compliance with all Regulatory requirements
Role Requirements
What you’ll bring to the role:
Essential Requirements:
• Bachelor/Masters in Science or...
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Homeoffice
108.430,28€ pro Jahr
...quality and cGMP
compliance related matters and ensure that all aspects of the operational business comply
with cGMP legal and regulatory requirements and Sandoz internal requirements.
Your key responsibilities:
Your responsibilities include, but are not...
Teilzeitarbeit
Homeoffice
108.430,28€ pro Jahr
...manufacturing and operational excellence through adherence to all necessary quality, HSE, ethics & risk and compliance as well as regulatory requirements.
• Establish and maintain strong relationship with both Novartis internal and external stakeholders, in particular...
73.112,9€ pro Jahr
...Desirable requirements (optional):
• Working with Siemens Polarion or a similar Product Life Cycle Management system
• Knowledge of regulatory standards for medical devices and/or combination products.
Why Novartis?
Our purpose is to reimagine medicine to improve...
Teilzeitarbeit
Homeoffice
