Revolution Medicines
Senior Director, Regulatory Affairs, Europe(m/w/x)
Vollzeitmit HomeofficeSenior
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
NONovartis Pharma AG
Global Regulatory Affairs Director (Neuroscience)(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Global regulatory strategy for neuroscience development programs. Global regulatory affairs experience required. 4-day work week.
Anforderungen
- BSc or MSc in science-based discipline
- Global regulatory affairs experience
- Pharmaceutical development experience
- Leading complex global regulatory strategies
- Neuroscience regulatory experience (ideal)
- Innovative disease regulatory experience (ideal)
- Rare disease regulatory experience (ideal)
- Major global submissions experience
- Registration submissions experience
- Accelerated pathways submissions experience
- Lifecycle variations submissions experience
- Health Authority engagement understanding
- Regulatory guidance interpretation understanding
- Strategic negotiations understanding
- Core member of Global Program Teams
- Influencing development strategy
- Influencing approval strategy
- Influencing lifecycle strategy
- Excellent communication skills
- Excellent influencing skills
- Excellent problem-solving skills
Aufgaben
- Lead regulatory strategy for Neuroscience development programmes
- Define and drive regulatory strategy aligned with product profile
- Integrate Health Authority and regional team inputs
- Identify and mitigate regulatory risks and opportunities
- Develop and communicate global regulatory strategies
- Manage Health Authority interactions and negotiations
- Provide strategic input to development plans and labelling
- Lead global regulatory submission planning and oversight
- Review and ensure quality of regulatory submissions
- Ensure compliance with global regulatory requirements
- Support accelerated and complex regulatory submissions
- Lead and align global regulatory sub-teams
- Coach and mentor regulatory colleagues
- Represent Regulatory Affairs on program teams and task forces
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharma AG 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?
- Novartis Pharma AG
Clinical Development Director (Neuroscience)(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Revolution Medicines
Director, CMC Regulatory, Europe(m/w/x)
Vollzeitmit HomeofficeManagementBasel - Novartis
Therapeutic Area Strategy Director, Neuroscience(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Novartis
Therapeutic Area Strategy Director, Neuroscience(m/w/x)
Vollzeitmit HomeofficeSeniorBasel
NONovartis Pharma AG
Global Regulatory Affairs Director (Neuroscience)(m/w/x)
Basel
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Global regulatory strategy for neuroscience development programs. Global regulatory affairs experience required. 4-day work week.
Anforderungen
- BSc or MSc in science-based discipline
- Global regulatory affairs experience
- Pharmaceutical development experience
- Leading complex global regulatory strategies
- Neuroscience regulatory experience (ideal)
- Innovative disease regulatory experience (ideal)
- Rare disease regulatory experience (ideal)
- Major global submissions experience
- Registration submissions experience
- Accelerated pathways submissions experience
- Lifecycle variations submissions experience
- Health Authority engagement understanding
- Regulatory guidance interpretation understanding
- Strategic negotiations understanding
- Core member of Global Program Teams
- Influencing development strategy
- Influencing approval strategy
- Influencing lifecycle strategy
- Excellent communication skills
- Excellent influencing skills
- Excellent problem-solving skills
Aufgaben
- Lead regulatory strategy for Neuroscience development programmes
- Define and drive regulatory strategy aligned with product profile
- Integrate Health Authority and regional team inputs
- Identify and mitigate regulatory risks and opportunities
- Develop and communicate global regulatory strategies
- Manage Health Authority interactions and negotiations
- Provide strategic input to development plans and labelling
- Lead global regulatory submission planning and oversight
- Review and ensure quality of regulatory submissions
- Ensure compliance with global regulatory requirements
- Support accelerated and complex regulatory submissions
- Lead and align global regulatory sub-teams
- Coach and mentor regulatory colleagues
- Represent Regulatory Affairs on program teams and task forces
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharma AG 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
Novartis Pharma AG
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen setzt sich für Vielfalt, Chancengleichheit und Inklusion ein und fördert innovative Lösungen zur Verbesserung der Patientenversorgung.
Noch nicht perfekt?
- Revolution Medicines
Senior Director, Regulatory Affairs, Europe(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Novartis Pharma AG
Clinical Development Director (Neuroscience)(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Revolution Medicines
Director, CMC Regulatory, Europe(m/w/x)
Vollzeitmit HomeofficeManagementBasel - Novartis
Therapeutic Area Strategy Director, Neuroscience(m/w/x)
Vollzeitmit HomeofficeSeniorBasel - Novartis
Therapeutic Area Strategy Director, Neuroscience(m/w/x)
Vollzeitmit HomeofficeSeniorBasel