BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Full-timeOn-siteSenior
Mainz, München
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GI
Gilead SciencesSr. Director Head of Regulatory Affairs Germany(m/w/x)
München
Full-timeOn-siteSenior
Description
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •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
Education
Bachelor's degree
Work Experience
14 years
Tasks
- •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
Languages
English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Gilead Sciences 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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GI
Gilead SciencesSr. Director Head of Regulatory Affairs Germany(m/w/x)
München
Full-timeOn-siteSenior
New Job?Nejo!
The AI Job Search Engine
Description
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •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
Education
Bachelor's degree
Work Experience
14 years
Tasks
- •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
Languages
English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Gilead Sciences 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
Gilead Sciences
Industry
Pharmaceuticals
Description
The company is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.
Not a perfect match?
- BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
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Full-timeOn-siteSeniorMünchen