Roche
Global Head of Product Development Regulatory(m/w/x)
Vollzeitnur vor OrtSenior
Basel
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BEBeOne Medicines I GmbH
Vice President, Regulatory Affairs, Europe and International(m/w/x)
Basel
VollzeitVor OrtBerufserfahren
AI/ML
Nejo KI-Zusammenfassung
Building and leading regulatory groups for cancer drug development at a biotech firm focused on oncology. Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs required. Leadership team representation, extensive international collaboration.
Anforderungen
- Thorough understanding of drug development process and pharmaceutical industry
- Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs
- Strong business acumen
- Very strong strategic skills
- Proven ability to deliver on goals in a cross-functional team
- Willingness to explore new technologies and processes
- Strong leadership of people
- Excellent verbal and written skills
- Skilled in conflict resolution and negotiation
- Strong negotiating skills and creativity
- Proven ability to build trust and respect
- Proficiency in Microsoft Office applications and Veeva Vault
- Flexibility to work when needed
Aufgaben
- Build and lead regulatory groups
- Develop and implement regulatory strategies
- Ensure compliance with regulatory requirements and standards
- Provide strategic regulatory oversight for projects
- Represent regulatory affairs on leadership teams
- Interface with EMA and national regulators
- Provide insights on evolving regulatory policies
- Manage line management and performance development
- Establish and manage high-performance regulatory teams
- Build partnerships with key stakeholders
- Maintain trusting relationships with regulators
- Create a supportive environment for the regulatory team
- Provide strategic direction and mentorship on projects
- Apply knowledge of drug development and regulatory requirements
- Maintain up-to-date regulatory knowledge and understanding
- Ensure high quality of CTAs and MAAs
- Support establishment of new affiliates
- Develop and execute local regulatory strategies
- Leverage new technologies for efficient submissions
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Microsoft Office applications
- Veeva Vault
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines I GmbH 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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Vollzeitnur vor OrtSeniorBasel
BEBeOne Medicines I GmbH
Vice President, Regulatory Affairs, Europe and International(m/w/x)
Basel
VollzeitVor OrtBerufserfahren
AI/ML
Nejo KI-Zusammenfassung
Building and leading regulatory groups for cancer drug development at a biotech firm focused on oncology. Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs required. Leadership team representation, extensive international collaboration.
Anforderungen
- Thorough understanding of drug development process and pharmaceutical industry
- Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs
- Strong business acumen
- Very strong strategic skills
- Proven ability to deliver on goals in a cross-functional team
- Willingness to explore new technologies and processes
- Strong leadership of people
- Excellent verbal and written skills
- Skilled in conflict resolution and negotiation
- Strong negotiating skills and creativity
- Proven ability to build trust and respect
- Proficiency in Microsoft Office applications and Veeva Vault
- Flexibility to work when needed
Aufgaben
- Build and lead regulatory groups
- Develop and implement regulatory strategies
- Ensure compliance with regulatory requirements and standards
- Provide strategic regulatory oversight for projects
- Represent regulatory affairs on leadership teams
- Interface with EMA and national regulators
- Provide insights on evolving regulatory policies
- Manage line management and performance development
- Establish and manage high-performance regulatory teams
- Build partnerships with key stakeholders
- Maintain trusting relationships with regulators
- Create a supportive environment for the regulatory team
- Provide strategic direction and mentorship on projects
- Apply knowledge of drug development and regulatory requirements
- Maintain up-to-date regulatory knowledge and understanding
- Ensure high quality of CTAs and MAAs
- Support establishment of new affiliates
- Develop and execute local regulatory strategies
- Leverage new technologies for efficient submissions
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Microsoft Office applications
- Veeva Vault
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines I GmbH 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
BeOne Medicines I GmbH
Branche
Pharmaceuticals
Beschreibung
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
Noch nicht perfekt?
- Roche
Global Head of Product Development Regulatory(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Regulatory Labeling Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Roche
Senior Vice President - Global Head of Safety Risk Management(m/w/x)
Vollzeitnur vor OrtManagementBasel - Revolution Medicines
Vice President, Communications, Public Affairs and Policy Advocacy(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Novartis
Head Legal Medical Affairs, International(m/w/x)
Vollzeitnur vor OrtSeniorBasel