Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - GI and Inflammation(m/w/x)
Vollzeitnur vor OrtSenior
Zürich
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TATakeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - Oncology(m/w/x)
Zürich
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Developing EUCAN regulatory strategies for novel oncology pharmaceuticals, managing investigational and marketing submissions. Minimum 8 years drug regulatory experience with advanced therapeutic products required. Extensive international collaboration with health authorities.
Anforderungen
- BSc, advanced scientific degree, or BA
- Minimum 8 years drug regulatory experience
- Experience with advanced therapeutic medical products
- Solid regulatory experience and HA interaction
- Understanding of evidence requirements
- Ability to formulate regional regulatory strategy
- Management of regulatory development procedures
- Experience with MA and lifecycle management
- Assertive authority and advisory skills
- Concise and respectful external communication
- Strategic planning and risk assessment skills
- Ability to propose risk mitigation plans
- Support for inclusion and individual growth
- Active listening and open dialogue skills
- Prioritization and execution skills
- Tactical decision-making ability
- Adaptability and relationship building skills
- Influence in global cross-functional teams
- Feedback exchange and idea expression
- Self-awareness and resilience
- Fluency in written and spoken English
Aufgaben
- Develop and lead regional regulatory strategies
- Manage submissions for investigational and marketing applications
- Lead interactions with regional health authorities
- Communicate submission plans and success probabilities
- Direct the Submission Working Group
- Provide tactical advice on product lifecycle management
- Mentor and guide assigned team members
- Collaborate with value and access teams
- Monitor emerging regional regulations and trends
- Evaluate new business development opportunities
- Maintain regulatory planning and filing documents
- Author and review internal regulatory procedures
- Interpret complex scientific issues for requirements
- Support innovative patient access initiatives
- Build relationships with external regulatory stakeholders
- Oversee vendors to ensure timely approvals
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Cell & gene therapy
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Takeda Pharmaceuticals International 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.
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TATakeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - Oncology(m/w/x)
Zürich
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Developing EUCAN regulatory strategies for novel oncology pharmaceuticals, managing investigational and marketing submissions. Minimum 8 years drug regulatory experience with advanced therapeutic products required. Extensive international collaboration with health authorities.
Anforderungen
- BSc, advanced scientific degree, or BA
- Minimum 8 years drug regulatory experience
- Experience with advanced therapeutic medical products
- Solid regulatory experience and HA interaction
- Understanding of evidence requirements
- Ability to formulate regional regulatory strategy
- Management of regulatory development procedures
- Experience with MA and lifecycle management
- Assertive authority and advisory skills
- Concise and respectful external communication
- Strategic planning and risk assessment skills
- Ability to propose risk mitigation plans
- Support for inclusion and individual growth
- Active listening and open dialogue skills
- Prioritization and execution skills
- Tactical decision-making ability
- Adaptability and relationship building skills
- Influence in global cross-functional teams
- Feedback exchange and idea expression
- Self-awareness and resilience
- Fluency in written and spoken English
Aufgaben
- Develop and lead regional regulatory strategies
- Manage submissions for investigational and marketing applications
- Lead interactions with regional health authorities
- Communicate submission plans and success probabilities
- Direct the Submission Working Group
- Provide tactical advice on product lifecycle management
- Mentor and guide assigned team members
- Collaborate with value and access teams
- Monitor emerging regional regulations and trends
- Evaluate new business development opportunities
- Maintain regulatory planning and filing documents
- Author and review internal regulatory procedures
- Interpret complex scientific issues for requirements
- Support innovative patient access initiatives
- Build relationships with external regulatory stakeholders
- Oversee vendors to ensure timely approvals
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Cell & gene therapy
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Takeda Pharmaceuticals International 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
Takeda Pharmaceuticals International AG
Branche
Pharmaceuticals
Beschreibung
The company is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Noch nicht perfekt?
- Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - GI and Inflammation(m/w/x)
Vollzeitnur vor OrtSeniorZürich - Takeda Pharmaceuticals International AG
Manager, International Clinical Trial Regulatory Lead(m/w/x)
Vollzeitnur vor OrtManagementZürich - CSL Behring L.L.C.
Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg - AstraZeneca
Senior Medical Affairs Leader, Breast(m/w/x)
Vollzeitnur vor OrtSeniorBaar - Takeda Pharmaceuticals International AG
GRA CMC Director - Marketed Products Development Lead(m/w/x)
Vollzeitnur vor OrtManagementZürich