Boehringer Ingelheim
CMC RA Manager(m/w/x)
Vollzeitnur vor OrtSenior
Ingelheim am Rhein, Biberach
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BOBoehringer Ingelheim
Senior CMC RA Manager(m/w/x)
Ingelheim am Rhein, Biberach
VollzeitVor OrtSenior
AI/ML
Nejo KI-Zusammenfassung
Global CMC regulatory management for small molecules, peptides, and oligonucleotides. In-depth international regulatory knowledge required. Collaboration with licensing partners.
Anforderungen
- Master’s degree in life science disciplines
- Experience in CMC development, pharmaceutical production, quality control, or quality assurance
- Global CMC regulatory experience in small molecules and drug-device combination products
- In-depth knowledge of international CMC regulatory requirements
- Leading strategic initiatives and driving regulatory strategy
- Ability to lead and motivate cross-functional teams
- Setting directions and managing changes
- Inter-disciplinary mindset
- Innovative and strategic thinking
- Teamwork skills
- Excellent organizational skills
- Excellent communication skills
- Strong prioritization capabilities
- Strong time management capabilities
- English fluency (written and spoken)
Aufgaben
- Manage global CMC regulatory activities for development projects
- Manage global CMC regulatory activities for approved products
- Support complex projects involving small molecules, peptides, and oligonucleotides
- Collaborate with licensing partners on projects
- Monitor developments in strategically important regulatory areas
- Assess impact of regulatory developments on Boehringer Ingelheim
- Provide insights to Regulatory Affairs colleagues
- Provide insights to other key functions
- 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 for CTAs
- Define global Module 3 documentation for MAAs
- Review 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
- Stay up-to-date on ICH regulations
- Stay up-to-date on FDA regulations
- Stay up-to-date on EMA regulations
- Stay up-to-date on PMDA regulations
- Stay up-to-date on CDE regulations
- Stay up-to-date on Emerging Markets regulations
- 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
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.
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BOBoehringer Ingelheim
Senior CMC RA Manager(m/w/x)
Ingelheim am Rhein, Biberach
VollzeitVor OrtSenior
AI/ML
Nejo KI-Zusammenfassung
Global CMC regulatory management for small molecules, peptides, and oligonucleotides. In-depth international regulatory knowledge required. Collaboration with licensing partners.
Anforderungen
- Master’s degree in life science disciplines
- Experience in CMC development, pharmaceutical production, quality control, or quality assurance
- Global CMC regulatory experience in small molecules and drug-device combination products
- In-depth knowledge of international CMC regulatory requirements
- Leading strategic initiatives and driving regulatory strategy
- Ability to lead and motivate cross-functional teams
- Setting directions and managing changes
- Inter-disciplinary mindset
- Innovative and strategic thinking
- Teamwork skills
- Excellent organizational skills
- Excellent communication skills
- Strong prioritization capabilities
- Strong time management capabilities
- English fluency (written and spoken)
Aufgaben
- Manage global CMC regulatory activities for development projects
- Manage global CMC regulatory activities for approved products
- Support complex projects involving small molecules, peptides, and oligonucleotides
- Collaborate with licensing partners on projects
- Monitor developments in strategically important regulatory areas
- Assess impact of regulatory developments on Boehringer Ingelheim
- Provide insights to Regulatory Affairs colleagues
- Provide insights to other key functions
- 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 for CTAs
- Define global Module 3 documentation for MAAs
- Review 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
- Stay up-to-date on ICH regulations
- Stay up-to-date on FDA regulations
- Stay up-to-date on EMA regulations
- Stay up-to-date on PMDA regulations
- Stay up-to-date on CDE regulations
- Stay up-to-date on Emerging Markets regulations
- 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
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
CMC RA Manager(m/w/x)
Vollzeitnur vor OrtSeniorIngelheim am Rhein, Biberach - 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 - IQVIA CSMS GmbH
Regulatory Affairs Manager Diabetologie(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz - BioNTech SE
(Associate) Director Protein & ADC Drug Product(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München