Sobi
Global Publication Manager(m/w/x)
Vollzeitmit HomeofficeSenior
Basel
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SOSobi
Global Regulatory CMC Lead(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Developing global CMC strategies for rare disease therapies, leading SME teams on eCTD Quality modules. 7-10 years in CMC Regulatory Affairs, expertise in global regulatory requirements required. Focus on innovative therapies for rare diseases.
Anforderungen
- BSc in Life Science or Advanced Degree
- 7-10 years experience in CMC Regulatory Affairs
- Expertise in global regulatory CMC requirements
- Experience in product registrations and lifecycle management
- Beneficial experience in clinical phase CMC development
- Ability to manage Health Authority interactions
- Knowledge of global regulatory guidelines
- Fluency in English
- Effective verbal and written communication skills
- High computer literacy in Office software
- Preferred experience with Veeva
- Adherence to Sobi core values
- Attention to detail and problem-solving abilities
- Good judgement in communicating risks
- Ability to represent Regulatory CMC in teams
- Ability to develop solutions for complex issues
- Independent motivation and detail-orientation
Aufgaben
- Develop global regulatory CMC strategies
- Ensure rapid approval of marketing applications
- Write and compile CMC submission sections
- Lead SME teams on eCTD Quality modules
- Review dossier data to identify risks
- Collaborate with stakeholders on risk mitigation
- Manage Health Authority inquiries effectively
- Negotiate with Health Authorities on CMC issues
- Maintain project plans for CMC submissions
- Evaluate manufacturing changes for global impact
- Provide guidance on ICH and FDA guidelines
- Align strategies with contract manufacturing partners
- Represent CMC on cross-functional project teams
- Store regulatory information in Veeva systems
Berufserfahrung
- 7 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Word
- Excel
- PowerPoint
- Veeva
Benefits
Attraktive Vergütung
- Competitive compensation
Familienfreundlichkeit
- Emphasis on work/life balance
Karriere- und Weiterentwicklung
- Professional growth opportunities
Sonstige Vorteile
- Diversity and Inclusion
Sinnstiftende Arbeit
- Meaningful work
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sobi 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?
- Roche
CMC Expert Drug Product Synthetic Molecule Parenterals (Peptide Launch)(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Sobi
Principal Medical Writer(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Sobi
External Quality Operation Manager (EQOM)(m/w/x)
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SOSobi
Global Regulatory CMC Lead(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Developing global CMC strategies for rare disease therapies, leading SME teams on eCTD Quality modules. 7-10 years in CMC Regulatory Affairs, expertise in global regulatory requirements required. Focus on innovative therapies for rare diseases.
Anforderungen
- BSc in Life Science or Advanced Degree
- 7-10 years experience in CMC Regulatory Affairs
- Expertise in global regulatory CMC requirements
- Experience in product registrations and lifecycle management
- Beneficial experience in clinical phase CMC development
- Ability to manage Health Authority interactions
- Knowledge of global regulatory guidelines
- Fluency in English
- Effective verbal and written communication skills
- High computer literacy in Office software
- Preferred experience with Veeva
- Adherence to Sobi core values
- Attention to detail and problem-solving abilities
- Good judgement in communicating risks
- Ability to represent Regulatory CMC in teams
- Ability to develop solutions for complex issues
- Independent motivation and detail-orientation
Aufgaben
- Develop global regulatory CMC strategies
- Ensure rapid approval of marketing applications
- Write and compile CMC submission sections
- Lead SME teams on eCTD Quality modules
- Review dossier data to identify risks
- Collaborate with stakeholders on risk mitigation
- Manage Health Authority inquiries effectively
- Negotiate with Health Authorities on CMC issues
- Maintain project plans for CMC submissions
- Evaluate manufacturing changes for global impact
- Provide guidance on ICH and FDA guidelines
- Align strategies with contract manufacturing partners
- Represent CMC on cross-functional project teams
- Store regulatory information in Veeva systems
Berufserfahrung
- 7 - 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Word
- Excel
- PowerPoint
- Veeva
Benefits
Attraktive Vergütung
- Competitive compensation
Familienfreundlichkeit
- Emphasis on work/life balance
Karriere- und Weiterentwicklung
- Professional growth opportunities
Sonstige Vorteile
- Diversity and Inclusion
Sinnstiftende Arbeit
- Meaningful work
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sobi 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
Sobi
Branche
Pharmaceuticals
Beschreibung
The company is a specialized biopharmaceutical company dedicated to rare diseases and committed to developing innovative therapies.
Noch nicht perfekt?
- Sobi
Global Publication Manager(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Roche
CMC Expert Drug Product Synthetic Molecule Parenterals (Peptide Launch)(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Sobi
Principal Medical Writer(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Sobi
External Quality Operation Manager (EQOM)(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Sobi
External Manufacturing Manager(m/w/x)
Vollzeitmit HomeofficeSeniorBasel