Merz Therapeutics
Regulatory CMC Writing Manager(m/w/x)
Vollzeitmit HomeofficeManagement
Frankfurt am Main
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SASanofi-Aventis Deutschland GmbH
Regulatory Site Officer(m/w/x)
Frankfurt am Main
Vollzeitmit HomeofficeBerufserfahren
AI/ML
Nejo KI-Zusammenfassung
Evaluating manufacturing procedures for regulatory compliance of cardiovascular medicines. 1-5 years direct Regulatory CMC experience preferred. Flexible working time models.
Anforderungen
- Desirable technical pharmaceutical CMC experience
- Preferred 1-5 years direct Regulatory CMC experience
- Knowledge of global regulations and guidelines
- Strategic thinking for technical and regulatory issues
- Initiative, independent thinking, and anticipatory foresight
- Effective communication to internal and external audiences
- Ability to make decisions in moving environments
- Knowledge of Chemical and Biological products
- Skills for internal data management systems
- Ph.D, Master in science/health, or equivalent
- Fluency in German and English language
Aufgaben
- Assess manufacturing and control procedures for regulatory compliance
- Evaluate and decide on the regulatory impact of product changes
- Organize site meetings to manage regulatory activities
- Participate in global meetings regarding regulatory changes
- Communicate regulatory timelines and approval statuses to QA functions
- Provide regulatory expertise for new product introductions and technologies
- Advise on change management for transfer projects
- Write submission-ready CMC documents using optimized terminology
- Support worldwide marketing authorizations and site registrations
- Collect GMP-related documents from manufacturing sites
- Coordinate regulatory requests following dossier variations
- Prepare answers for Health Authority inquiries with site experts
- Act as the interface between Global Regulatory Affairs and manufacturing
- Collaborate on standard operating procedures with regulatory context
- Support continuous improvement of regulatory working processes
- Prepare for and participate in inspections as a subject matter expert
- Optimize the use of company software for regulatory management
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- internal data management systems
- documentation tools
Benefits
Modernes Büro
- Modern working environment
Flexibles Arbeiten
- Hybrid working models
- Flexible working time models
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sanofi-Aventis Deutschland 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.
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SASanofi-Aventis Deutschland GmbH
Regulatory Site Officer(m/w/x)
Frankfurt am Main
Vollzeitmit HomeofficeBerufserfahren
AI/ML
Nejo KI-Zusammenfassung
Evaluating manufacturing procedures for regulatory compliance of cardiovascular medicines. 1-5 years direct Regulatory CMC experience preferred. Flexible working time models.
Anforderungen
- Desirable technical pharmaceutical CMC experience
- Preferred 1-5 years direct Regulatory CMC experience
- Knowledge of global regulations and guidelines
- Strategic thinking for technical and regulatory issues
- Initiative, independent thinking, and anticipatory foresight
- Effective communication to internal and external audiences
- Ability to make decisions in moving environments
- Knowledge of Chemical and Biological products
- Skills for internal data management systems
- Ph.D, Master in science/health, or equivalent
- Fluency in German and English language
Aufgaben
- Assess manufacturing and control procedures for regulatory compliance
- Evaluate and decide on the regulatory impact of product changes
- Organize site meetings to manage regulatory activities
- Participate in global meetings regarding regulatory changes
- Communicate regulatory timelines and approval statuses to QA functions
- Provide regulatory expertise for new product introductions and technologies
- Advise on change management for transfer projects
- Write submission-ready CMC documents using optimized terminology
- Support worldwide marketing authorizations and site registrations
- Collect GMP-related documents from manufacturing sites
- Coordinate regulatory requests following dossier variations
- Prepare answers for Health Authority inquiries with site experts
- Act as the interface between Global Regulatory Affairs and manufacturing
- Collaborate on standard operating procedures with regulatory context
- Support continuous improvement of regulatory working processes
- Prepare for and participate in inspections as a subject matter expert
- Optimize the use of company software for regulatory management
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- internal data management systems
- documentation tools
Benefits
Modernes Büro
- Modern working environment
Flexibles Arbeiten
- Hybrid working models
- Flexible working time models
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sanofi-Aventis Deutschland 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
Sanofi-Aventis Deutschland GmbH
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen bietet Arzneimittel zur Prävention von Herz-Kreislauf-Erkrankungen an und setzt sich für die Verbesserung der Lebensqualität ein.
Noch nicht perfekt?
- Merz Therapeutics
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