Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - Oncology(m/w/x)
Full-timeOn-siteSenior
Zürich
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TATakeda Pharmaceuticals International AG
Manager, International Clinical Trial Regulatory Lead(m/w/x)
Zürich
Full-timeOn-siteManagement
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Takeda Pharmaceuticals International AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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TATakeda Pharmaceuticals International AG
Manager, International Clinical Trial Regulatory Lead(m/w/x)
Zürich
Full-timeOn-siteManagement
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Takeda Pharmaceuticals International AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Takeda Pharmaceuticals International AG
Industry
Pharmaceuticals
Description
The company is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Not a perfect match?
- Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - Oncology(m/w/x)
Full-timeOn-siteSeniorZürich - Takeda Pharmaceuticals International AG
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GRA CMC Director - Marketed Products Development Lead(m/w/x)
Full-timeOn-siteManagementZürich - CSL Behring AG (CH)
Regional Regulatory Lead – APAC, LATAM & Partner Business(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - CSL Behring L.L.C.
Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Full-timeOn-siteSeniorGlattbrugg