Boehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NCE(m/w/x)
Vollzeitnur vor OrtSenior
Biberach, Ingelheim am Rhein
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BOBoehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NBE(m/w/x)
Ingelheim am Rhein, Biberach
ab USD 80.000 - 100.000 / Jahr
VollzeitVor OrtSenior
AI/ML
Nejo KI-Zusammenfassung
Managing CMC regulatory activities for biologicals, including advice on global requirements and submission strategies. Several years of global CMC regulatory experience for biologicals and drug-device combination products required. Unlimited PTO, 401k matching.
Anforderungen
- Master's degree in Biotechnology, Biochemistry, Pharmacy, Chemistry, or Biology
- Experience in CMC development and/or production/control of biologicals
- Several years' experience in global CMC regulatory for biologicals and drug-device combination products
- Experience in Antibody-Drug Conjugate (ADCs) advantageous
- In-depth knowledge of international CMC regulatory requirements
- Track record of leading strategic initiatives
- Driving regulatory strategy
- Proven ability to lead and motivate people in cross-functional teams
- Set direction and manage changes
- Inter-disciplinary mindset
- Innovative and strategic thinking
- Team player
- Excellent organizational skills
- Excellent communication skills
- Strong prioritization capabilities
- Strong time management capabilities
Aufgaben
- Manage CMC regulatory activities for biologicals
- Represent the department in global project teams
- Represent the department in global product teams
- Provide CMC regulatory advice on global requirements
- Provide CMC regulatory advice on submission strategies
- Provide CMC regulatory advice on seeking scientific advice
- Plan global Module 3 documentation
- Define global Module 3 documentation
- Review global Module 3 documentation
- Compile global Module 3 documentation for CTAs
- Compile global Module 3 documentation for MAAs
- Compile global Module 3 documentation for post-approval activities
- Compile global Module 3 documentation for post-approval changes
- Compile global Module 3 documentation for renewals
- Guide project teams in preparing registration documents
- Guide project teams in preparing responses to health authorities
- Review CMC documentation for in-licensing products
- Drive innovative regulatory strategies
- Drive acceleration of regulatory strategies
- Utilize AI tools for regulatory strategies
- Contribute to interdisciplinary strategic projects internally
- Represent Boehringer Ingelheim in industry organizations externally
- Stay up-to-date on global CMC regulatory environment
- Coach less experienced colleagues
- Deputize for the team lead when needed
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- ICH
- FDA
- PMDA
- EU
Benefits
Gesundheits- & Fitnessangebote
- Health insurance
Betriebliche Altersvorsorge
- 401k matching
Mehr Urlaubstage
- Unlimited PTO
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?
- Boehringer Ingelheim
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BOBoehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NBE(m/w/x)
Ingelheim am Rhein, Biberach
ab USD 80.000 - 100.000 / Jahr
VollzeitVor OrtSenior
AI/ML
Nejo KI-Zusammenfassung
Managing CMC regulatory activities for biologicals, including advice on global requirements and submission strategies. Several years of global CMC regulatory experience for biologicals and drug-device combination products required. Unlimited PTO, 401k matching.
Anforderungen
- Master's degree in Biotechnology, Biochemistry, Pharmacy, Chemistry, or Biology
- Experience in CMC development and/or production/control of biologicals
- Several years' experience in global CMC regulatory for biologicals and drug-device combination products
- Experience in Antibody-Drug Conjugate (ADCs) advantageous
- In-depth knowledge of international CMC regulatory requirements
- Track record of leading strategic initiatives
- Driving regulatory strategy
- Proven ability to lead and motivate people in cross-functional teams
- Set direction and manage changes
- Inter-disciplinary mindset
- Innovative and strategic thinking
- Team player
- Excellent organizational skills
- Excellent communication skills
- Strong prioritization capabilities
- Strong time management capabilities
Aufgaben
- Manage CMC regulatory activities for biologicals
- Represent the department in global project teams
- Represent the department in global product teams
- Provide CMC regulatory advice on global requirements
- Provide CMC regulatory advice on submission strategies
- Provide CMC regulatory advice on seeking scientific advice
- Plan global Module 3 documentation
- Define global Module 3 documentation
- Review global Module 3 documentation
- Compile global Module 3 documentation for CTAs
- Compile global Module 3 documentation for MAAs
- Compile global Module 3 documentation for post-approval activities
- Compile global Module 3 documentation for post-approval changes
- Compile global Module 3 documentation for renewals
- Guide project teams in preparing registration documents
- Guide project teams in preparing responses to health authorities
- Review CMC documentation for in-licensing products
- Drive innovative regulatory strategies
- Drive acceleration of regulatory strategies
- Utilize AI tools for regulatory strategies
- Contribute to interdisciplinary strategic projects internally
- Represent Boehringer Ingelheim in industry organizations externally
- Stay up-to-date on global CMC regulatory environment
- Coach less experienced colleagues
- Deputize for the team lead when needed
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- ICH
- FDA
- PMDA
- EU
Benefits
Gesundheits- & Fitnessangebote
- Health insurance
Betriebliche Altersvorsorge
- 401k matching
Mehr Urlaubstage
- Unlimited PTO
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?
- Boehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NCE(m/w/x)
Vollzeitnur vor OrtSeniorBiberach, Ingelheim am Rhein - Boehringer Ingelheim
Global Regulatory Strategy Lead(m/w/x)
Vollzeitnur vor OrtSeniorIngelheim am Rhein - BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - BioNTech SE
Director AS&T Projects & Strategy(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
(Associate) Director Protein & ADC Drug Product(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München