Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - Oncology(m/w/x)
Vollzeitnur vor OrtSenior
Zürich
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TATakeda Pharmaceuticals International AG
Manager, International Clinical Trial Regulatory Lead(m/w/x)
Zürich
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Global CTA submissions management for novel specialty pharmaceuticals in EUCAN/GEM. 3+ years drug regulatory affairs experience, preferably in EU/GEM regions, required. Broad international regulatory exposure with novel specialty pharmaceuticals.
Anforderungen
- BSc. advanced scientific related degree preferred or BA accepted based on experience
- Minimum of 3 years of experience in drug regulatory affairs preferably within the EU/GEM region
- Experience with EU CTR advantageous
- Solid regulatory experience including knowledge of CTA regulations and guidance governing drugs and biologics
- Basic regulatory procedure knowledge with major health authorities in the region
- Attention to detail and ability to make reasoned recommendations
- Ability to speak up
- Promotion of an inclusive culture and expression of empathy for others
- Ability to carry out assigned activities within reasonable time
- Adaptability to changing circumstances and ability to build and maintain relationships
- Ability to receive and give feedback; express ideas, questions, and disagreement
- Self-awareness and ability to function effectively under challenges
- Fluency in English
Aufgaben
- Contribute to regulatory strategy development for clinical trials in EUCAN and GEM regions
- Develop operational implementation plans for clinical trial applications (CTAs) in EUCAN and GEM regions
- Execute and oversee activities related to Requests for Information (RFI) and CTA management globally
- Ensure compliance with legal requirements and internal procedures for CTA submissions
- Track CTA activities and eTMF updates with the International CTRL/CRO Regulatory Lead
- Generate and maintain metrics on workload and KPIs for key CTA activities
- Oversee interactions with health authorities during CTA assessments
- Collaborate with global and regional counterparts on CTA regulatory activities
- Present regional CTA regulatory strategies to senior management
- Identify regional and national requirements for CTA submissions
- Coordinate submission preparations and creation of administrative documents for interventional trials
- Coordinate submission preparations for Non-Interventional Post-authorisation safety studies (PASS)
- Develop and maintain standardized communication and planning tools for internal use
- Ensure timely submissions and proactive communication of regulatory milestones
- Provide regulatory oversight of CRO activities to maintain compliance
- Support non-routine submission activities and deviation follow-up as needed
- Provide ad-hoc guidance on submission requirements for clinical trials
- Collaborate with the team to find solutions to problems during the CTA process
- Maintain an internal regulatory knowledge database on emerging trends
- Participate in the review of internal procedures and processes
- Ensure timely and compliant submissions to the EMA Clinical Trial Information System (CTIS)
- Coordinate submissions in the CTIS portal
- Represent the team in workshops and cross-functional initiatives related to clinical trials
- Engage Local Operating Company Regulatory Affairs in health authority interactions
Berufserfahrung
- 3 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 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
Manager, International Clinical Trial Regulatory Lead(m/w/x)
Zürich
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Global CTA submissions management for novel specialty pharmaceuticals in EUCAN/GEM. 3+ years drug regulatory affairs experience, preferably in EU/GEM regions, required. Broad international regulatory exposure with novel specialty pharmaceuticals.
Anforderungen
- BSc. advanced scientific related degree preferred or BA accepted based on experience
- Minimum of 3 years of experience in drug regulatory affairs preferably within the EU/GEM region
- Experience with EU CTR advantageous
- Solid regulatory experience including knowledge of CTA regulations and guidance governing drugs and biologics
- Basic regulatory procedure knowledge with major health authorities in the region
- Attention to detail and ability to make reasoned recommendations
- Ability to speak up
- Promotion of an inclusive culture and expression of empathy for others
- Ability to carry out assigned activities within reasonable time
- Adaptability to changing circumstances and ability to build and maintain relationships
- Ability to receive and give feedback; express ideas, questions, and disagreement
- Self-awareness and ability to function effectively under challenges
- Fluency in English
Aufgaben
- Contribute to regulatory strategy development for clinical trials in EUCAN and GEM regions
- Develop operational implementation plans for clinical trial applications (CTAs) in EUCAN and GEM regions
- Execute and oversee activities related to Requests for Information (RFI) and CTA management globally
- Ensure compliance with legal requirements and internal procedures for CTA submissions
- Track CTA activities and eTMF updates with the International CTRL/CRO Regulatory Lead
- Generate and maintain metrics on workload and KPIs for key CTA activities
- Oversee interactions with health authorities during CTA assessments
- Collaborate with global and regional counterparts on CTA regulatory activities
- Present regional CTA regulatory strategies to senior management
- Identify regional and national requirements for CTA submissions
- Coordinate submission preparations and creation of administrative documents for interventional trials
- Coordinate submission preparations for Non-Interventional Post-authorisation safety studies (PASS)
- Develop and maintain standardized communication and planning tools for internal use
- Ensure timely submissions and proactive communication of regulatory milestones
- Provide regulatory oversight of CRO activities to maintain compliance
- Support non-routine submission activities and deviation follow-up as needed
- Provide ad-hoc guidance on submission requirements for clinical trials
- Collaborate with the team to find solutions to problems during the CTA process
- Maintain an internal regulatory knowledge database on emerging trends
- Participate in the review of internal procedures and processes
- Ensure timely and compliant submissions to the EMA Clinical Trial Information System (CTIS)
- Coordinate submissions in the CTIS portal
- Represent the team in workshops and cross-functional initiatives related to clinical trials
- Engage Local Operating Company Regulatory Affairs in health authority interactions
Berufserfahrung
- 3 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 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 - Oncology(m/w/x)
Vollzeitnur vor OrtSeniorZürich - Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - GI and Inflammation(m/w/x)
Vollzeitnur vor OrtSeniorZürich - Takeda Pharmaceuticals International AG
GRA CMC Director - Marketed Products Development Lead(m/w/x)
Vollzeitnur vor OrtManagementZürich - CSL Behring AG (CH)
Regional Regulatory Lead – APAC, LATAM & Partner Business(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg - CSL Behring L.L.C.
Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg