Director Global Regulatory Affairs Development Pipeline (Oncology)

Role Summary

Director Global Regulatory Affairs Development Pipeline (Oncology). Act as the Global Regulatory Lead for assigned development projects by defining and executing the Regulatory Strategy including the HA interaction strategy and developing the storyline for regulatory applications and dossiers during product development up to marketing authorisation.

Responsibilities

• Act as global regulatory lead for assigned development projects and define and execute the regulatory strategy from clinical development up to (including) marketing authorization
• Define the strategy for regulatory interactions for the assigned projects
• Plan, prepare and conduct interactions with national authorities and sovra-national agencies (e.g. MPA, PEI, EMA, FDA, as well as WHO when relevant) in the scope of product development incl. marketing authorization
• Define storyline for regulatory application and dossiers through product development up to marketing authorization
• Coordinate preparation, writing and reviewing of documents and dossiers (e.g. briefing books, IBs, MAA, variations)
• Contribute to the setup, adjustment and continuous optimization of regulatory processes, systems and interfaces
• Supervise vendors active in regulatory affairs on behalf of BioNTech
• Monitor of changes and evolution in the regulatory landscape for relevant product and/or product classes; analyze the impact of new regulations on assigned projects; contribute to build transparent relationships with regulatory agencies for the assigned projects

Qualifications

• University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) followed by 9+ years of relevant experience
• Experience in the development of antibody - and ADC-based cancer therapies; novel-novel combination therapy and companion diagnostic development experience a plus
• Team-oriented and solution-oriented mindset
• Experience in regulatory strategy planning and proven ability to plan, coordinate and lead activities
• Knowledge of multidisciplinary functions involved in drug development
• Business fluent English is a must

Skills

• Regulatory strategy development
• HA interaction planning
• Dossier preparation and management
• Cross-functional leadership
• Regulatory landscape monitoring

Education

• Bachelor’s or higher in natural sciences or equivalent

Additional Requirements

• Location: Cambridge, MA; Gaithersburg, MD; London, UK; Mainz, Germany; Munich, Germany; New Jersey, US (as applicable per posting)