BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Vollzeitnur vor OrtSenior
Mainz, München
Neuer Job?Nejo!
Die KI-Suchmaschine für Jobs
GI
Gilead SciencesSr. Director Head of Regulatory Affairs Germany(m/w/x)
München
VollzeitVor OrtSenior
Beschreibung
As the strategic lead for regulatory affairs in Germany, you will drive organizational vision and ensure compliance while mentoring a high-performing team to deliver life-changing innovations.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
Anforderungen
- •Expert leadership and cross-functional influence skills
- •Excellent vision and direction setting
- •Senior-level experience with HA and Trade Association
- •Expertise in regulatory strategy and HA discussions
- •Leadership of complex cross-functional projects
- •Expert people management and development experience
- •Extensive internal and external cross-functional networks
- •Expert influencing, negotiation, and decision-making skills
- •Excellent decision-making and prioritization skills
- •Excellent verbal and written English skills
- •16+ years RA experience or 14+ with advanced degree
- •Expert knowledge of ICH and regulatory requirements
- •Expertise in complex regulatory strategy and negotiations
- •Excellent knowledge of QA and pharmacovigilance
- •Expertise in leading cross-functional project teams
- •Excellent people management experience
- •Expert knowledge of national and regional HAs
Ausbildung
Bachelor-Abschluss
Berufserfahrung
14 Jahre
Aufgaben
- •Define vision and direction for the German regulatory organization
- •Provide strategic advice to the German leadership team
- •Ensure fulfillment of all marketing authorization requirements
- •Lead functional crisis management within the region
- •Manage German resource and budget planning
- •Communicate organizational changes to the regulatory team
- •Oversee professional development and succession planning
- •Direct all regulatory activities and deliverables in Germany
- •Advise on complex scientific and pre-submission meetings
- •Contribute to international and global regulatory strategies
- •Maintain compliance with local laws and global procedures
- •Participate in global improvement initiatives and taskforces
- •Advise promotional material review and quality assurance teams
- •Lead risk assessments and develop mitigation strategies
- •Monitor and prepare for changes in regulatory legislation
- •Mentor and coach regulatory and non-regulatory staff
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Gilead Sciences 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?
- Apellis
Senior Director, General Manager(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - Scholar Rock
Country Medical Director(m/w/x)
Vollzeitnur vor OrtSeniorFrankfurt am Main, München - BioNTech SE
Senior Director Quality Transformation and Oversight(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - argenx GmbH
Associate Director Marketing(m/w/x)
Vollzeitnur vor OrtSeniorMünchen
GI
Gilead SciencesSr. Director Head of Regulatory Affairs Germany(m/w/x)
München
VollzeitVor OrtSenior
Neuer Job?Nejo!
Die KI-Suchmaschine für Jobs
Beschreibung
As the strategic lead for regulatory affairs in Germany, you will drive organizational vision and ensure compliance while mentoring a high-performing team to deliver life-changing innovations.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
Anforderungen
- •Expert leadership and cross-functional influence skills
- •Excellent vision and direction setting
- •Senior-level experience with HA and Trade Association
- •Expertise in regulatory strategy and HA discussions
- •Leadership of complex cross-functional projects
- •Expert people management and development experience
- •Extensive internal and external cross-functional networks
- •Expert influencing, negotiation, and decision-making skills
- •Excellent decision-making and prioritization skills
- •Excellent verbal and written English skills
- •16+ years RA experience or 14+ with advanced degree
- •Expert knowledge of ICH and regulatory requirements
- •Expertise in complex regulatory strategy and negotiations
- •Excellent knowledge of QA and pharmacovigilance
- •Expertise in leading cross-functional project teams
- •Excellent people management experience
- •Expert knowledge of national and regional HAs
Ausbildung
Bachelor-Abschluss
Berufserfahrung
14 Jahre
Aufgaben
- •Define vision and direction for the German regulatory organization
- •Provide strategic advice to the German leadership team
- •Ensure fulfillment of all marketing authorization requirements
- •Lead functional crisis management within the region
- •Manage German resource and budget planning
- •Communicate organizational changes to the regulatory team
- •Oversee professional development and succession planning
- •Direct all regulatory activities and deliverables in Germany
- •Advise on complex scientific and pre-submission meetings
- •Contribute to international and global regulatory strategies
- •Maintain compliance with local laws and global procedures
- •Participate in global improvement initiatives and taskforces
- •Advise promotional material review and quality assurance teams
- •Lead risk assessments and develop mitigation strategies
- •Monitor and prepare for changes in regulatory legislation
- •Mentor and coach regulatory and non-regulatory staff
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Gilead Sciences 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
Gilead Sciences
Branche
Pharmaceuticals
Beschreibung
The company is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.
Noch nicht perfekt?
- BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - Apellis
Senior Director, General Manager(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - Scholar Rock
Country Medical Director(m/w/x)
Vollzeitnur vor OrtSeniorFrankfurt am Main, München - BioNTech SE
Senior Director Quality Transformation and Oversight(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - argenx GmbH
Associate Director Marketing(m/w/x)
Vollzeitnur vor OrtSeniorMünchen