Galderma Austria
Regulatory Affairs Manager Alpine(m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Wien
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
ATAT10 AZ Österreich GmbH
Regulatory Affairs and Medical Compliance Assistant(m/w/x)
Wien
ab 46.768,8 / Jahr
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Preparing regulatory documents like Fachinformation and Gebrauchsinformation for healthcare products. 3+ years industry experience and fluent English/German required. Bonus opportunities and flexible hybrid work.
Anforderungen
- Matura/Abitur or equivalent education
- International baccalaureate or equivalent education
- At least 3 years' proven professional experience in industry or healthcare
- Command in English and German (written and spoken)
- Agile thinking with pragmatic approach
- Efficient, meticulous, self-motivated working style
- Project and process management experience
- Strong organizational skills, oversight, manage complexity under timelines
- Strong willingness to learn
- Proficient MS Office
- Ability to work with new technologies
- Innovative and creative ideas within regulated setting
- Strong interpersonal and team interaction skills
Aufgaben
- Conduct activities in line with company values and compliance standards
- Complete required training on the AZ Code of Conduct and policies
- Report potential non-compliance issues
- Maintain and develop Regulatory Sharepoints
- Prepare Fachinformation, Gebrauchsinformation, and Fachkurzinformation
- Document information on parallel imported products
- Handle generic administrative tasks
- Organize meetings, travel, and training
- Support budget monitoring and control
- Assist in product registration and maintenance
- Ensure compliance with local and global codes and standards
- Maintain and create RA SOPs and the Business Continuity Plan
- Organize yearly BCP testing
- Manage Regulatory Affairs digital and hardcopy archive
- Ensure appropriate archiving according to retention guidelines
- Support quality assurance and business compliance
- Cooperate with Medical Affairs Assistant for essential tasks
- Support Compliance Business Partner with Quarterly Compliance Monitoring
Berufserfahrung
- 3 Jahre
Ausbildung
- Matura
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- MS Office
Benefits
Boni & Prämien
- Bonus opportunities
Betriebliche Altersvorsorge
- Company pension scheme
Gesundheits- & Fitnessangebote
- Supplementary insurance
Flexibles Arbeiten
- Flexible working hours
- Hybrid work models
Weiterbildungsangebote
- Professional development support
Fokus auf Nachhaltigkeit
- Environmentally conscious company
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AT10 AZ Österreich GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- Flinn.ai
Senior Regulatory Affairs Specialist(m/w/x)
Vollzeitmit HomeofficeSeniorWien, Berlin - IQVIA Biotech
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Vollzeitmit HomeofficeJuniorWien - Galderma Austria
Quality Specialist & Deputy Responsible Person(m/w/x)
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Vollzeitmit HomeofficeBerufserfahrenWienab 4.000 / Monat
ATAT10 AZ Österreich GmbH
Regulatory Affairs and Medical Compliance Assistant(m/w/x)
Wien
ab 46.768,8 / Jahr
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Preparing regulatory documents like Fachinformation and Gebrauchsinformation for healthcare products. 3+ years industry experience and fluent English/German required. Bonus opportunities and flexible hybrid work.
Anforderungen
- Matura/Abitur or equivalent education
- International baccalaureate or equivalent education
- At least 3 years' proven professional experience in industry or healthcare
- Command in English and German (written and spoken)
- Agile thinking with pragmatic approach
- Efficient, meticulous, self-motivated working style
- Project and process management experience
- Strong organizational skills, oversight, manage complexity under timelines
- Strong willingness to learn
- Proficient MS Office
- Ability to work with new technologies
- Innovative and creative ideas within regulated setting
- Strong interpersonal and team interaction skills
Aufgaben
- Conduct activities in line with company values and compliance standards
- Complete required training on the AZ Code of Conduct and policies
- Report potential non-compliance issues
- Maintain and develop Regulatory Sharepoints
- Prepare Fachinformation, Gebrauchsinformation, and Fachkurzinformation
- Document information on parallel imported products
- Handle generic administrative tasks
- Organize meetings, travel, and training
- Support budget monitoring and control
- Assist in product registration and maintenance
- Ensure compliance with local and global codes and standards
- Maintain and create RA SOPs and the Business Continuity Plan
- Organize yearly BCP testing
- Manage Regulatory Affairs digital and hardcopy archive
- Ensure appropriate archiving according to retention guidelines
- Support quality assurance and business compliance
- Cooperate with Medical Affairs Assistant for essential tasks
- Support Compliance Business Partner with Quarterly Compliance Monitoring
Berufserfahrung
- 3 Jahre
Ausbildung
- Matura
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- MS Office
Benefits
Boni & Prämien
- Bonus opportunities
Betriebliche Altersvorsorge
- Company pension scheme
Gesundheits- & Fitnessangebote
- Supplementary insurance
Flexibles Arbeiten
- Flexible working hours
- Hybrid work models
Weiterbildungsangebote
- Professional development support
Fokus auf Nachhaltigkeit
- Environmentally conscious company
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AT10 AZ Österreich GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
AT10 AZ Österreich GmbH
Branche
Pharmaceuticals
Beschreibung
The company is committed to improving patient outcomes through innovative biopharmaceuticals and fostering an inclusive team environment.
Noch nicht perfekt?
- Galderma Austria
Regulatory Affairs Manager Alpine(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWien - Flinn.ai
Senior Regulatory Affairs Specialist(m/w/x)
Vollzeitmit HomeofficeSeniorWien, Berlin - IQVIA Biotech
Clinical Associate Regulatory Submissions(m/w/x)
Vollzeitmit HomeofficeJuniorWien - Galderma Austria
Quality Specialist & Deputy Responsible Person(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWien - IQVIA Biotech
Clinical Research Associate 2(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 4.000 / Monat