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
GRA CMC Director - Marketed Products Development Lead(m/w/x)
Zürich
Full-timeOn-siteManagement
Nejo AI Summary
Managing global regulatory submissions and post-approval lifecycle for marketed specialty pharmaceuticals. 10+ years regulatory experience with pharmaceutical ingredients and products required. Global scope, leading agency interactions for novel specialty pharmaceuticals.
Requirements
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
- 10+ years pharmaceutical Regulatory CMC experience or equivalent industry experience
- Experience with active pharmaceutical ingredient/drug substances, small molecules, drug products, biologics, analytical characterization, process scale-up or regulatory registration of products
- Expert in developing alternate strategies based on guidance/regulations
- Expert in liaising with Regulatory Agencies as lead in successful Agency Interactions
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development
- Ability to deal with issues of critical importance and provide regulatory advice
- Able to provide sound strategic advice and enable critical decisions under ambiguity
- Demonstrate leadership, problem-solving ability, flexibility, and values teamwork
- Demonstrate strategic enterprise thinking and ability to influence in a complex matrix environment
- Exercise good judgement in elevating and communicating issues to line management
- Build and maintain a team environment that inspires and enables progress
- Expert in CTD authoring and/or review skills throughout the product lifecycle
Tasks
- Manage regulatory submissions for global marketing applications
- Oversee post-approval lifecycle activities for assigned compounds
- Evaluate change proposals for global regulatory impact
- Plan global variations and amendments
- Interpret EMA, FDA, ICH, and WHO regulations for CMC compliance
- Lead team in establishing CMC content requirements for regulatory submissions
- Review submission content for compliance with established requirements
- Communicate developments impacting regulatory success to project teams and stakeholders
- Provide solutions to prevent recurrence of regulatory issues
- Interact with international Health Authorities and facilitate agency meetings
- Stay updated on evolving regulatory CMC requirements
- Apply regulatory knowledge to projects and support colleagues' development
- Maintain constructive relationships with colleagues and Health Authority representatives
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master'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
GRA CMC Director - Marketed Products Development Lead(m/w/x)
Zürich
Full-timeOn-siteManagement
Nejo AI Summary
Managing global regulatory submissions and post-approval lifecycle for marketed specialty pharmaceuticals. 10+ years regulatory experience with pharmaceutical ingredients and products required. Global scope, leading agency interactions for novel specialty pharmaceuticals.
Requirements
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
- 10+ years pharmaceutical Regulatory CMC experience or equivalent industry experience
- Experience with active pharmaceutical ingredient/drug substances, small molecules, drug products, biologics, analytical characterization, process scale-up or regulatory registration of products
- Expert in developing alternate strategies based on guidance/regulations
- Expert in liaising with Regulatory Agencies as lead in successful Agency Interactions
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development
- Ability to deal with issues of critical importance and provide regulatory advice
- Able to provide sound strategic advice and enable critical decisions under ambiguity
- Demonstrate leadership, problem-solving ability, flexibility, and values teamwork
- Demonstrate strategic enterprise thinking and ability to influence in a complex matrix environment
- Exercise good judgement in elevating and communicating issues to line management
- Build and maintain a team environment that inspires and enables progress
- Expert in CTD authoring and/or review skills throughout the product lifecycle
Tasks
- Manage regulatory submissions for global marketing applications
- Oversee post-approval lifecycle activities for assigned compounds
- Evaluate change proposals for global regulatory impact
- Plan global variations and amendments
- Interpret EMA, FDA, ICH, and WHO regulations for CMC compliance
- Lead team in establishing CMC content requirements for regulatory submissions
- Review submission content for compliance with established requirements
- Communicate developments impacting regulatory success to project teams and stakeholders
- Provide solutions to prevent recurrence of regulatory issues
- Interact with international Health Authorities and facilitate agency meetings
- Stay updated on evolving regulatory CMC requirements
- Apply regulatory knowledge to projects and support colleagues' development
- Maintain constructive relationships with colleagues and Health Authority representatives
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master'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.
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Full-timeOn-siteSeniorZürich - Takeda Pharmaceuticals International AG
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