Immatics N.V.
Associate Director Regulatory Affairs – CMC Lead(m/w/x)
Vollzeitmit HomeofficeManagement
München
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
FOFormycon AG
Team Lead Regulatory CMC Drug Product(m/w/x)
Planegg
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Aligning RegCMC DP strategy for biopharmaceutical development and approved products, focusing on drug-device combination products. Minimum 6 years of Regulatory CMC experience with parenteral products required. 30 days vacation, additional days off, and employer-supported pension.
Anforderungen
- Scientific background with master's degree or PhD
- Master's degree or PhD in biology, chemistry, biochemistry, pharmacy or equivalent
- Minimum 6 years experience in Regulatory CMC
- Experience with parenteral products
- Experience with drug-device combination products
- Thorough knowledge of drug development process
- Experience in multiple development phases up to submission
- Excellent staff leadership skills
- Excellent communication skills
- Fluency in written and spoken English
- Very good team player
- Result oriented
- Persistent
- Well organized
- Proactive
- Problem solver
- Able to work independently
- German work permit mandatory
Aufgaben
- Align RegCMC DP strategy for development projects and approved products
- Review and align strategy for essential concepts with focus on DP aspects
- Ensure timely preparation and review of regulatory documents
- Establish strategies for drug-device combination products
- Liaise with clinical department for human factor studies
- Oversee documentation package preparation and submission to Notified Bodies
- Coordinate design history file establishment and maintenance
- Guide RegCMC Drug Product team in submission strategies
- Support response strategies for authority requests
- Maintain knowledge of global regulatory landscape
- Participate in meetings with regulatory agencies
- Manage team capacity allocation
- Coordinate regulatory CROs for assigned work packages
- Compile and maintain budget and capacity plans
Berufserfahrung
- 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mehr Urlaubstage
- 30 days of vacation
- Additional days off
Sonstige Zulagen
- Formycon Mastercard
- Participation in international conferences
Betriebliche Altersvorsorge
- Employer-supported pension scheme
Gesundheits- & Fitnessangebote
- Comprehensive health & wellbeing offering
Sonstige Vorteile
- Occupational health services
- Group accident insurance
- Diversity focus
- Equal opportunity
Mitarbeiterrabatte
- Fitness discounts
Mentale Gesundheitsförderung
- Mental health support
Karriere- und Weiterentwicklung
- Individual development and career paths
Weiterbildungsangebote
- Internal trainings
- Participation in scientific events
Lockere Unternehmenskultur
- Collaborative culture
- Inclusive culture
- Respectful environment
Modernes Büro
- Modern working environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Formycon AG 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?
- Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - Ipsen Pharma GmbH
Senior Medical Lead - New Launches(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - Formycon AG
Senior Data Protection and Compliance Counsel(m/w/x)
Vollzeitmit HomeofficeSeniorPlanegg
FOFormycon AG
Team Lead Regulatory CMC Drug Product(m/w/x)
Planegg
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Aligning RegCMC DP strategy for biopharmaceutical development and approved products, focusing on drug-device combination products. Minimum 6 years of Regulatory CMC experience with parenteral products required. 30 days vacation, additional days off, and employer-supported pension.
Anforderungen
- Scientific background with master's degree or PhD
- Master's degree or PhD in biology, chemistry, biochemistry, pharmacy or equivalent
- Minimum 6 years experience in Regulatory CMC
- Experience with parenteral products
- Experience with drug-device combination products
- Thorough knowledge of drug development process
- Experience in multiple development phases up to submission
- Excellent staff leadership skills
- Excellent communication skills
- Fluency in written and spoken English
- Very good team player
- Result oriented
- Persistent
- Well organized
- Proactive
- Problem solver
- Able to work independently
- German work permit mandatory
Aufgaben
- Align RegCMC DP strategy for development projects and approved products
- Review and align strategy for essential concepts with focus on DP aspects
- Ensure timely preparation and review of regulatory documents
- Establish strategies for drug-device combination products
- Liaise with clinical department for human factor studies
- Oversee documentation package preparation and submission to Notified Bodies
- Coordinate design history file establishment and maintenance
- Guide RegCMC Drug Product team in submission strategies
- Support response strategies for authority requests
- Maintain knowledge of global regulatory landscape
- Participate in meetings with regulatory agencies
- Manage team capacity allocation
- Coordinate regulatory CROs for assigned work packages
- Compile and maintain budget and capacity plans
Berufserfahrung
- 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mehr Urlaubstage
- 30 days of vacation
- Additional days off
Sonstige Zulagen
- Formycon Mastercard
- Participation in international conferences
Betriebliche Altersvorsorge
- Employer-supported pension scheme
Gesundheits- & Fitnessangebote
- Comprehensive health & wellbeing offering
Sonstige Vorteile
- Occupational health services
- Group accident insurance
- Diversity focus
- Equal opportunity
Mitarbeiterrabatte
- Fitness discounts
Mentale Gesundheitsförderung
- Mental health support
Karriere- und Weiterentwicklung
- Individual development and career paths
Weiterbildungsangebote
- Internal trainings
- Participation in scientific events
Lockere Unternehmenskultur
- Collaborative culture
- Inclusive culture
- Respectful environment
Modernes Büro
- Modern working environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Formycon AG 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
Formycon AG
Branche
Pharmaceuticals
Beschreibung
Formycon is a leading developer of biopharmaceutical medicines, especially biosimilars, spanning the entire value chain from development to regulatory approval.
Noch nicht perfekt?
- Immatics N.V.
Associate Director Regulatory Affairs – CMC Lead(m/w/x)
Vollzeitmit HomeofficeManagementMünchen - Alnylam Pharmaceuticals, Inc.
Associate Director, Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - Immatics N.V.
Associate Director Regulatory Affairs – Clinical Lead*(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - Ipsen Pharma GmbH
Senior Medical Lead - New Launches(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - Formycon AG
Senior Data Protection and Compliance Counsel(m/w/x)
Vollzeitmit HomeofficeSeniorPlanegg