Takeda Pharmaceuticals International AG
Manager, International Clinical Trial Regulatory Lead(m/w/x)
Full-timeOn-siteManagement
Zürich
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TATakeda Pharmaceuticals International AG
Associate Director, Senior International Clinical Trial Regulatory Lead(m/w/x)
Zürich
Full-timeOn-siteManagement
Nejo AI Summary
Global clinical trial regulatory strategy and operational planning for EUCAN/GEM regions. 8+ years regulatory affairs experience and team leadership required. 4-day work week, 6 weeks vacation.
Requirements
- BSc. Advanced scientific degree preferred; BA accepted based on experience
- Minimum 8 years hands-on regulatory affairs experience
- Several years managing and leading a team
- Expertise in regulatory document preparation and submission for EU clinical trials
- Strong understanding of EU pharmaceutical development lifecycle and regulatory standards
- In-depth experience with regulatory submissions
- Comprehensive knowledge of CTR and CTIS
- Excellent written and verbal communication abilities
- Proactive approach to sharing insights and fostering knowledge exchange
- Capability to lead cross-functional teams
- Cultivate effective, collaborative relationships
- Motivated to contribute to dynamic, fast-growing team
- Values integrity, fairness, honesty, perseverance, and teamwork
- Experience supporting regulatory authority inspections advantageous
- Proficiency in GxP audits advantageous
- Manage regulatory development procedures with limited supervision
- Assertive authority whom peers trust for advice
- Communicates externally/with authorities in concise and respectful language
- Develops concise strategic plans
- Outlines opportunities and risks of alternative scenarios
- Proposes risk mitigation plans
- Acts as an ally to support individuals
- Promotes an inclusive culture
- Practices active listening
- Encourages open dialogue, feedback, and diverse opinions
- Prioritise activities and execute within reasonable time
- Tactical decision-making ability
- Adapts to changing circumstances
- Builds and maintains relationships
- Voice heard as remote participant in global/cross-functional teams
- Influences meeting agendas & outcomes for regional strategic needs
- Receives and gives feedback
- Expresses ideas, questions, and disagreement
- Self-aware and functions effectively
- Meets challenges with energy, vitality, and confidence
Tasks
- Contribute to regulatory strategy development for clinical trials in EUCAN and GEM regions
- Develop operational plans for clinical trial applications (CTAs) in EUCAN and GEM
- Manage CTA submissions from initial submission through lifecycle
- Align CTA plans with global submission strategy
- Oversee CTA creation, submission, and maintenance globally
- Execute CTA activities in Europe via CTIS or legacy processes
- Ensure compliance with legal requirements and Takeda procedures
- Track CTA activities and eTMF updates performed by CROs
- Collaborate with CROs to ensure compliance
- Provide strategic and tactical CTA regulatory advice
- Guide leadership teams on timely and efficient program conduct
- Maintain compliance with applicable regulatory requirements
- Manage CTA interactions with regional health authorities
- Mentor team members and provide guidance
- Oversee CTA interactions with health authorities during application assessment
- Act as deputy to Head International Regulatory Clinical Trials
- Manage and plan CTA regulatory activities
- Work with Takeda Global and Regional counterparts
- Present regional CTA regulatory strategies to leadership
- Identify regional/national requirements for CTA submissions
- Coordinate CTA submission preparations
- Create administrative documents for CTA submissions
- Coordinate submissions for Non-Interventional Post-authorisation safety studies (PASS)
- Build and strengthen external stakeholder contacts
- Ensure accurate and timely submissions
- Communicate key regulatory milestones proactively
- Provide regulatory oversight of CRO activities
- Support non-routine submission activities and deviation follow-up
- Provide ad-hoc guidance on submission requirements
- Propose solutions to CTA process problems
- Contribute to internal regulatory knowledge database
- Coordinate submissions in the CTIS portal
- Represent the Team in workshops and initiatives
- Ensure involvement of LOCs RA representatives in HA interactions
- Participate in reviews of internal procedures
- Co-author internal procedures and processes
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- CTR
- CTIS
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
Associate Director, Senior International Clinical Trial Regulatory Lead(m/w/x)
Zürich
Full-timeOn-siteManagement
Nejo AI Summary
Global clinical trial regulatory strategy and operational planning for EUCAN/GEM regions. 8+ years regulatory affairs experience and team leadership required. 4-day work week, 6 weeks vacation.
Requirements
- BSc. Advanced scientific degree preferred; BA accepted based on experience
- Minimum 8 years hands-on regulatory affairs experience
- Several years managing and leading a team
- Expertise in regulatory document preparation and submission for EU clinical trials
- Strong understanding of EU pharmaceutical development lifecycle and regulatory standards
- In-depth experience with regulatory submissions
- Comprehensive knowledge of CTR and CTIS
- Excellent written and verbal communication abilities
- Proactive approach to sharing insights and fostering knowledge exchange
- Capability to lead cross-functional teams
- Cultivate effective, collaborative relationships
- Motivated to contribute to dynamic, fast-growing team
- Values integrity, fairness, honesty, perseverance, and teamwork
- Experience supporting regulatory authority inspections advantageous
- Proficiency in GxP audits advantageous
- Manage regulatory development procedures with limited supervision
- Assertive authority whom peers trust for advice
- Communicates externally/with authorities in concise and respectful language
- Develops concise strategic plans
- Outlines opportunities and risks of alternative scenarios
- Proposes risk mitigation plans
- Acts as an ally to support individuals
- Promotes an inclusive culture
- Practices active listening
- Encourages open dialogue, feedback, and diverse opinions
- Prioritise activities and execute within reasonable time
- Tactical decision-making ability
- Adapts to changing circumstances
- Builds and maintains relationships
- Voice heard as remote participant in global/cross-functional teams
- Influences meeting agendas & outcomes for regional strategic needs
- Receives and gives feedback
- Expresses ideas, questions, and disagreement
- Self-aware and functions effectively
- Meets challenges with energy, vitality, and confidence
Tasks
- Contribute to regulatory strategy development for clinical trials in EUCAN and GEM regions
- Develop operational plans for clinical trial applications (CTAs) in EUCAN and GEM
- Manage CTA submissions from initial submission through lifecycle
- Align CTA plans with global submission strategy
- Oversee CTA creation, submission, and maintenance globally
- Execute CTA activities in Europe via CTIS or legacy processes
- Ensure compliance with legal requirements and Takeda procedures
- Track CTA activities and eTMF updates performed by CROs
- Collaborate with CROs to ensure compliance
- Provide strategic and tactical CTA regulatory advice
- Guide leadership teams on timely and efficient program conduct
- Maintain compliance with applicable regulatory requirements
- Manage CTA interactions with regional health authorities
- Mentor team members and provide guidance
- Oversee CTA interactions with health authorities during application assessment
- Act as deputy to Head International Regulatory Clinical Trials
- Manage and plan CTA regulatory activities
- Work with Takeda Global and Regional counterparts
- Present regional CTA regulatory strategies to leadership
- Identify regional/national requirements for CTA submissions
- Coordinate CTA submission preparations
- Create administrative documents for CTA submissions
- Coordinate submissions for Non-Interventional Post-authorisation safety studies (PASS)
- Build and strengthen external stakeholder contacts
- Ensure accurate and timely submissions
- Communicate key regulatory milestones proactively
- Provide regulatory oversight of CRO activities
- Support non-routine submission activities and deviation follow-up
- Provide ad-hoc guidance on submission requirements
- Propose solutions to CTA process problems
- Contribute to internal regulatory knowledge database
- Coordinate submissions in the CTIS portal
- Represent the Team in workshops and initiatives
- Ensure involvement of LOCs RA representatives in HA interactions
- Participate in reviews of internal procedures
- Co-author internal procedures and processes
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- CTR
- CTIS
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
Manager, International Clinical Trial Regulatory Lead(m/w/x)
Full-timeOn-siteManagementZürich - Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - Oncology(m/w/x)
Full-timeOn-siteSeniorZürich - Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - GI and Inflammation(m/w/x)
Full-timeOn-siteSeniorZürich - Takeda Pharmaceuticals International AG
Associate Director, Site Start Up and Maintenance(m/w/x)
Full-timeOn-siteManagementZürich - CSL Behring L.L.C.
Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Full-timeOn-siteSeniorGlattbrugg