Beschreibung

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.

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

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