Boehringer Ingelheim
Global Regulatory Strategy Lead(m/w/x)
Full-timeOn-siteSenior
Ingelheim am Rhein
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BIBioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Mainz, München
Full-timeOn-siteSenior
Nejo AI Summary
Defining regulatory strategy for antibody/ADC cancer therapies, including novel combination and companion diagnostics, at biotech firm. 9+ years experience with antibody/ADC cancer therapy regulatory processes required. Directing global market authorization for novel cancer therapies.
Requirements
- 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
Tasks
- 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
Work Experience
- 9 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BIBioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Mainz, München
Full-timeOn-siteSenior
Nejo AI Summary
Defining regulatory strategy for antibody/ADC cancer therapies, including novel combination and companion diagnostics, at biotech firm. 9+ years experience with antibody/ADC cancer therapy regulatory processes required. Directing global market authorization for novel cancer therapies.
Requirements
- 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
Tasks
- 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
Work Experience
- 9 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Not a perfect match?
- Boehringer Ingelheim
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Director Clinical Operations(m/w/x)
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Director Translational Sciences (Oncology)(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Full-timeOn-siteSeniorMainz