Boehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NBE(m/w/x)
Vollzeitnur vor OrtSenior
Ingelheim am Rhein, Biberach
ab USD 80.000 - 100.000 / Jahr
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BOBoehringer Ingelheim
Regional Regulatory Lead(m/w/x)
Ingelheim am Rhein
ab USD 80.000 - 100.000 / Jahr
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
EU/Canada regulatory strategy for human pharma products, including pediatric development and clinical trial applications. Several years of hands-on RA experience in the region required. Unlimited PTO, 401k matching.
Anforderungen
- Master’s or bachelor’s degree in pharmacy or life sciences
- Several years of pharmaceutical industry experience in Regulatory Affairs in Human Pharma
- Experience in functions outside of RA highly desirable
- Regulatory affairs 'hands on' experience in the region
- Understanding of cultures and their impact
- Practical experience handling new developments
- Practical experience handling registrations
- Practical experience handling maintenance of registered products
- Outstanding ability in negotiating
- Outstanding ability in managing projects
- Knowledge of interacting with health authorities
- Capability to apply scientific expertise
- Readiness to apply scientific expertise
- Capability to participate in informed scientific dialogues
- Readiness to participate in informed scientific dialogues
- Critical thinking
- Aptitude to self-manage workload
- Ability to reorganize priorities
- Ability to meet tight deadlines
- Proficiency in English communication, verbal
- Proficiency in English communication, written
Aufgaben
- Provide robust regulatory strategy for assigned products/projects
- Guide maintenance and development needs in EUCAN region
- Address pediatric development requirements
- Manage clinical trial applications
- Plan and coordinate regulatory submissions for marketing authorization maintenance
- Oversee regulatory submissions for marketing authorization maintenance
- Organize meetings with regulatory authorities in EUCAN countries
- Schedule meetings with regulatory authorities in EUCAN countries
- Carry out in-person meetings with regulatory authorities
- Carry out remote meetings with regulatory authorities
- Contribute to Regulatory Excellence Team meetings
- Support development of worldwide regulatory strategies
- Act as interface for RA functions in ROPUs and OPUs in EUCAN
- Act as contact partner for RA functions in ROPUs and OPUs in EUCAN
- Liaise with Global RA for assigned products/projects
- Liaise with other cross-functional stakeholders for assigned products/projects
- Serve as EMA contact for products under EU centralized procedure
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Gesundheits- & Fitnessangebote
- Health insurance
Betriebliche Altersvorsorge
- 401k matching
Mehr Urlaubstage
- Unlimited PTO
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Boehringer Ingelheim 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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Vollzeitnur vor OrtSeniorMainz
BOBoehringer Ingelheim
Regional Regulatory Lead(m/w/x)
Ingelheim am Rhein
ab USD 80.000 - 100.000 / Jahr
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
EU/Canada regulatory strategy for human pharma products, including pediatric development and clinical trial applications. Several years of hands-on RA experience in the region required. Unlimited PTO, 401k matching.
Anforderungen
- Master’s or bachelor’s degree in pharmacy or life sciences
- Several years of pharmaceutical industry experience in Regulatory Affairs in Human Pharma
- Experience in functions outside of RA highly desirable
- Regulatory affairs 'hands on' experience in the region
- Understanding of cultures and their impact
- Practical experience handling new developments
- Practical experience handling registrations
- Practical experience handling maintenance of registered products
- Outstanding ability in negotiating
- Outstanding ability in managing projects
- Knowledge of interacting with health authorities
- Capability to apply scientific expertise
- Readiness to apply scientific expertise
- Capability to participate in informed scientific dialogues
- Readiness to participate in informed scientific dialogues
- Critical thinking
- Aptitude to self-manage workload
- Ability to reorganize priorities
- Ability to meet tight deadlines
- Proficiency in English communication, verbal
- Proficiency in English communication, written
Aufgaben
- Provide robust regulatory strategy for assigned products/projects
- Guide maintenance and development needs in EUCAN region
- Address pediatric development requirements
- Manage clinical trial applications
- Plan and coordinate regulatory submissions for marketing authorization maintenance
- Oversee regulatory submissions for marketing authorization maintenance
- Organize meetings with regulatory authorities in EUCAN countries
- Schedule meetings with regulatory authorities in EUCAN countries
- Carry out in-person meetings with regulatory authorities
- Carry out remote meetings with regulatory authorities
- Contribute to Regulatory Excellence Team meetings
- Support development of worldwide regulatory strategies
- Act as interface for RA functions in ROPUs and OPUs in EUCAN
- Act as contact partner for RA functions in ROPUs and OPUs in EUCAN
- Liaise with Global RA for assigned products/projects
- Liaise with other cross-functional stakeholders for assigned products/projects
- Serve as EMA contact for products under EU centralized procedure
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Gesundheits- & Fitnessangebote
- Health insurance
Betriebliche Altersvorsorge
- 401k matching
Mehr Urlaubstage
- Unlimited PTO
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Boehringer Ingelheim 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
Boehringer Ingelheim
Branche
Pharmaceuticals
Beschreibung
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
Noch nicht perfekt?
- Boehringer Ingelheim
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Vollzeitnur vor OrtSeniorMainz, München - Boehringer Ingelheim
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Vollzeitnur vor OrtSeniorBiberach, Ingelheim am Rhein - IQVIA CSMS GmbH
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Vollzeitnur vor OrtBerufserfahrenMainz - BioNTech SE
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Vollzeitnur vor OrtSeniorMainz