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
Associate Director, EUCAN Regulatory Lead - GI and Inflammation(m/w/x)
Zürich
Full-timeOn-siteSenior
Nejo AI Summary
Regional strategy development for gastrointestinal and inflammation drug assets across European and Canadian markets. Minimum 8 years of pharmaceutical regulatory affairs experience required. Flexible working hours, 30 days vacation.
Requirements
- BSc in advanced scientific field or BA
- 8 years drug regulatory affairs experience
- Solid regulatory experience and guideline interpretation
- Understanding of evidence requirements for access
- Ability to formulate regional regulatory strategy
- Management of regulatory development and lifecycles
- Experience with initial MA and submissions
- Natural, assertive authority and peer trust
- Concise and respectful communication with authorities
- Development of concise strategic plans
- Proposal of risk mitigation plans
- Support for individuals and inclusive culture
- Active listening and encouragement of dialogue
- Prioritization and execution within reasonable time
- Ability to take tactical decisions
- Adaptability and relationship building skills
- Influence on global cross-functional teams
- Ability to give and receive feedback
- Self-awareness and resilience under challenge
- Fluency in English
- Willingness to travel up to 30%
Tasks
- Lead regional regulatory strategy for assigned assets
- Drive submission excellence across development and registration
- Manage product life-cycle to enable patient access
- Define and develop progressive regulatory strategies
- Align strategies with line management for success
- Strengthen product development plans through regulatory expertise
- Oversee investigational and market application submissions
- Communicate regional regulatory strategies and timelines
- Assess likelihood of success and impact of trends
- Mentor and provide strategic guidance to team members
- Provide tactical advice on development and life-cycle management
- Lead the Submission Working Group
- Represent the region on global project teams
- Lead interactions with regional health authorities
- Support value and access teams with HTA bodies
- Plan and execute regional regulatory submissions
- Collaborate with local and global cross-functional teams
- Act as deputy to the regional therapeutic lead
- Present regulatory strategies to senior management
- Monitor emerging regional regulations and guidance
- Provide strategic advice on future business needs
- Track and fulfill post-marketing commitments
- Evaluate new business development and due diligence opportunities
- Maintain regulatory planning and filing documents
- Author and review internal procedures and processes
- Interpret complex scientific issues for regulatory strategy
- Implement innovative patient access strategies
- Partner with access functions on regulatory documentation
- Build relationships with consultants and business partners
- Strengthen influence with external stakeholders and agencies
- Coordinate with vendors to ensure timely approvals
- Negotiate with authorities on behalf of project teams
- Prepare and lead Health Authority meetings
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Flexible Working
- Flexible work hours
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, EUCAN Regulatory Lead - GI and Inflammation(m/w/x)
Zürich
Full-timeOn-siteSenior
Nejo AI Summary
Regional strategy development for gastrointestinal and inflammation drug assets across European and Canadian markets. Minimum 8 years of pharmaceutical regulatory affairs experience required. Flexible working hours, 30 days vacation.
Requirements
- BSc in advanced scientific field or BA
- 8 years drug regulatory affairs experience
- Solid regulatory experience and guideline interpretation
- Understanding of evidence requirements for access
- Ability to formulate regional regulatory strategy
- Management of regulatory development and lifecycles
- Experience with initial MA and submissions
- Natural, assertive authority and peer trust
- Concise and respectful communication with authorities
- Development of concise strategic plans
- Proposal of risk mitigation plans
- Support for individuals and inclusive culture
- Active listening and encouragement of dialogue
- Prioritization and execution within reasonable time
- Ability to take tactical decisions
- Adaptability and relationship building skills
- Influence on global cross-functional teams
- Ability to give and receive feedback
- Self-awareness and resilience under challenge
- Fluency in English
- Willingness to travel up to 30%
Tasks
- Lead regional regulatory strategy for assigned assets
- Drive submission excellence across development and registration
- Manage product life-cycle to enable patient access
- Define and develop progressive regulatory strategies
- Align strategies with line management for success
- Strengthen product development plans through regulatory expertise
- Oversee investigational and market application submissions
- Communicate regional regulatory strategies and timelines
- Assess likelihood of success and impact of trends
- Mentor and provide strategic guidance to team members
- Provide tactical advice on development and life-cycle management
- Lead the Submission Working Group
- Represent the region on global project teams
- Lead interactions with regional health authorities
- Support value and access teams with HTA bodies
- Plan and execute regional regulatory submissions
- Collaborate with local and global cross-functional teams
- Act as deputy to the regional therapeutic lead
- Present regulatory strategies to senior management
- Monitor emerging regional regulations and guidance
- Provide strategic advice on future business needs
- Track and fulfill post-marketing commitments
- Evaluate new business development and due diligence opportunities
- Maintain regulatory planning and filing documents
- Author and review internal procedures and processes
- Interpret complex scientific issues for regulatory strategy
- Implement innovative patient access strategies
- Partner with access functions on regulatory documentation
- Build relationships with consultants and business partners
- Strengthen influence with external stakeholders and agencies
- Coordinate with vendors to ensure timely approvals
- Negotiate with authorities on behalf of project teams
- Prepare and lead Health Authority meetings
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Flexible Working
- Flexible work hours
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)
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Sr. Dir., Global Regulatory Team Leader – Hematology & LCM Europe(m/w/x)
Full-timeOn-siteSeniorGlattbrugg - CSL Vifor
Associate Director Market Access, Partner Business(m/w/x)
Full-timeOn-siteSeniorOpfikon - CSL Behring AG (CH)
Regional Regulatory Lead – APAC, LATAM & Partner Business(m/w/x)
Full-timeOn-siteSeniorGlattbrugg