Director Global Regulatory Affairs (Oncology)(m/w/x)

Vollzeit

Senior

Keine Angabe

Mainz, München

Nejo KI-Zusammenfassung

In this role, you will lead global regulatory efforts for development projects, shaping strategies for interactions with health authorities and overseeing the preparation of essential regulatory documents. Your expertise will help navigate the evolving regulatory landscape and ensure successful product authorization.

Lass KI die perfekten Jobs für dich finden!

Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.

Anforderungen

•University degree in natural sciences or equivalent
•9+ years of working experience in Regulatory Affairs
•Experience in development of antibody- and ADC-based cancer therapies
•Experience in novel combination therapy and companion diagnostic development
•Team-oriented and solution-oriented mindset
•Experience in regulatory strategy planning
•Proven ability to plan, coordinate and lead activities
•Knowledge of multidisciplinary functions in drug development
•Business fluent English

Bachelor-Abschluss

Berufserfahrung

9 Jahre

Deine Aufgaben

•Act as Global Regulatory Lead for assigned development projects
•Define and execute the Regulatory Strategy from clinical development to marketing authorization
•Plan, prepare, and conduct interactions with national and supranational authorities
•Define the strategy for regulatory interactions for assigned projects
•Develop the storyline for regulatory applications and dossiers
•Coordinate the preparation, writing, and reviewing of regulatory documents
•Contribute to the setup and optimization of regulatory processes and systems
•Represent Global Regulatory Affairs in cross-functional initiatives
•Supervise vendors involved in regulatory affairs
•Monitor changes in the regulatory landscape and analyze their impact
•Build transparent relationships with regulatory agencies for assigned projects

Sprachen

Englisch – verhandlungssicher

Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE 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.

Ähnliche Jobs direkt in deine Inbox?