Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - GI and Inflammation(m/w/x)
Full-timeOn-siteSenior
Zürich
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TATakeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - Oncology(m/w/x)
Zürich
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Cell & gene therapy
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 - Oncology(m/w/x)
Zürich
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Cell & gene therapy
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 - GI and Inflammation(m/w/x)
Full-timeOn-siteSeniorZürich - Takeda Pharmaceuticals International AG
Manager, International Clinical Trial Regulatory Lead(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 - AstraZeneca
Senior Medical Affairs Leader, Breast(m/w/x)
Full-timeOn-siteSeniorBaar - Takeda Pharmaceuticals International AG
GRA CMC Director - Marketed Products Development Lead(m/w/x)
Full-timeOn-siteManagementZürich