BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Full-timeOn-siteSenior
Mainz, München
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BOBoehringer Ingelheim
Global Regulatory Strategy Lead(m/w/x)
Ingelheim am Rhein
Full-timeOn-siteSenior
Nejo AI Summary
Leading cross-functional teams in developing global strategy documents for innovative therapies. Long-term pharma/biotech experience with CRM therapeutic area expertise required. Global scope across early clinical development projects.
Requirements
- Advanced degree in pharmacy or life sciences
- Specialized Pharmacist or Regulatory Affairs Master's
- Long term pharmaceutical or biotechnology experience
- Deep understanding of Global Regulatory Affairs
- Therapeutic area expertise in CRM
- Track record in global regulatory strategies
- Experience with (s)BLA, (s)NDA, or MAA
- Negotiation experience with FDA or EMA
- Knowledge of global guidelines and SOPs
- Ability to analyze complex scientific data
- Calm and focused approach under pressure
- Excellent interpersonal and leadership skills
- High business acumen and strategic thinking
- Persuasive written and verbal communication
- Strong decision-making and problem-solving capabilities
Tasks
- Act as the primary regulatory interface for cross-functional teams
- Lead the Regulatory Excellence Team for assigned projects
- Develop and execute innovative global regulatory strategies
- Author the Global Regulatory Strategy document
- Contribute to Target Product Profiles and target labels
- Drive regulatory interactions with health authorities in strategic markets
- Collaborate with regional and local regulatory colleagues
- Provide strategic input on clinical trial protocols and study reports
- Review CTAs, INDs, and pediatric development plans
- Review core dossier components for regulatory submissions
- Ensure compliance with global regulatory standards
- Implement departmental policies and best practices
- Monitor scientific and regulatory developments in the CRM area
- Integrate pharmacovigilance and market access insights into strategies
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- (s)BLA
- (s)NDA
- MAA
- INDs
- CTAs
- FDA
- EMA
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Boehringer Ingelheim 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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BOBoehringer Ingelheim
Global Regulatory Strategy Lead(m/w/x)
Ingelheim am Rhein
Full-timeOn-siteSenior
Nejo AI Summary
Leading cross-functional teams in developing global strategy documents for innovative therapies. Long-term pharma/biotech experience with CRM therapeutic area expertise required. Global scope across early clinical development projects.
Requirements
- Advanced degree in pharmacy or life sciences
- Specialized Pharmacist or Regulatory Affairs Master's
- Long term pharmaceutical or biotechnology experience
- Deep understanding of Global Regulatory Affairs
- Therapeutic area expertise in CRM
- Track record in global regulatory strategies
- Experience with (s)BLA, (s)NDA, or MAA
- Negotiation experience with FDA or EMA
- Knowledge of global guidelines and SOPs
- Ability to analyze complex scientific data
- Calm and focused approach under pressure
- Excellent interpersonal and leadership skills
- High business acumen and strategic thinking
- Persuasive written and verbal communication
- Strong decision-making and problem-solving capabilities
Tasks
- Act as the primary regulatory interface for cross-functional teams
- Lead the Regulatory Excellence Team for assigned projects
- Develop and execute innovative global regulatory strategies
- Author the Global Regulatory Strategy document
- Contribute to Target Product Profiles and target labels
- Drive regulatory interactions with health authorities in strategic markets
- Collaborate with regional and local regulatory colleagues
- Provide strategic input on clinical trial protocols and study reports
- Review CTAs, INDs, and pediatric development plans
- Review core dossier components for regulatory submissions
- Ensure compliance with global regulatory standards
- Implement departmental policies and best practices
- Monitor scientific and regulatory developments in the CRM area
- Integrate pharmacovigilance and market access insights into strategies
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- (s)BLA
- (s)NDA
- MAA
- INDs
- CTAs
- FDA
- EMA
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Boehringer Ingelheim 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
Boehringer Ingelheim
Industry
Pharmaceuticals
Description
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
Not a perfect match?
- BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Full-timeOn-siteSeniorMainz, München - BioNTech SE
Senior Director, Safety Sciences Lead(m/w/x)
Full-timeOn-siteSeniorMainz, München - BioNTech SE
(Senior-) Director Clinical Development(m/w/x)
Full-timeOn-siteSeniorMainz, München - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Manager QA Compliance(m/w/x)
Full-timeOn-siteSeniorMainz