BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Vollzeitnur vor OrtSenior
Mainz, München
Neuer Job?Nejo!
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BOBoehringer Ingelheim
Global Regulatory Strategy Lead(m/w/x)
Ingelheim am Rhein
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- (s)BLA
- (s)NDA
- MAA
- INDs
- CTAs
- FDA
- EMA
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Boehringer Ingelheim erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- BioNTech SE
Senior Director, Safety Sciences Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - Boehringer Ingelheim
Senior CMC RA Manager(m/w/x)
Vollzeitnur vor OrtSeniorIngelheim am Rhein, Biberach - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
(Senior-) Director Clinical Development(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München
BOBoehringer Ingelheim
Global Regulatory Strategy Lead(m/w/x)
Ingelheim am Rhein
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- (s)BLA
- (s)NDA
- MAA
- INDs
- CTAs
- FDA
- EMA
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Boehringer Ingelheim erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Boehringer Ingelheim
Branche
Pharmaceuticals
Beschreibung
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
Noch nicht perfekt?
- BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - BioNTech SE
Senior Director, Safety Sciences Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - Boehringer Ingelheim
Senior CMC RA Manager(m/w/x)
Vollzeitnur vor OrtSeniorIngelheim am Rhein, Biberach - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
(Senior-) Director Clinical Development(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München