Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - Oncology(m/w/x)
Full-timeOn-siteSenior
Zürich
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GLGlaxoSmithKline GmbH & Co. KG
Associate Director, Global Regulatory Strategy (GRS)(m/w/x)
Baar
Full-timeOn-siteSenior
Nejo AI Summary
Developing global regulatory strategies for oncology medicines, ensuring optimal labeling and approvals. Oncology Global Regulatory Affairs expertise required. Cross-functional team collaboration, matrix environment.
Requirements
- Bachelor’s degree in Biological or Healthcare Science
- Experience in all drug development phases
- Experience in Oncology Global Regulatory Affairs
- Expertise in leading global/regional development, submission, approval
- Knowledge of clinical trial and licensing requirements
- Ability to derive compliant solutions to regulatory challenges
- Strong written communication skills
- PhD in Biological or Healthcare Science
- Knowledge of oncology therapy areas
- Proficiency in digital fluency tools
Tasks
- Lead and execute regulatory strategies
- Ensure optimal labeling and approvals
- Maintain compliance with internal and external requirements
- Work in cross-functional and matrix environments
- Develop and implement global/regional regulatory strategy
- Align with Medicines Development Strategy and Integrated Asset Plan
- Collaborate with Early/Medicine Development Teams
- Work with Global Regulatory Lead
- Ensure robust regulatory strategies
- Manage interactions with regulatory authorities
- Handle reviews and submissions
- Collaborate with commercial teams
- Secure best possible labeling
- Assess regulatory intelligence
- Evaluate precedents and competitive landscape
- Inform strategy development
- Improve decision-making
- Ensure compliance with regulatory requirements
- Foster strong matrix working relationships
- Facilitate dialogue across teams
- Drive process improvement
- Promote innovation
- Enhance performance excellence
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- digital fluency tools
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of GlaxoSmithKline GmbH & Co. KG 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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GLGlaxoSmithKline GmbH & Co. KG
Associate Director, Global Regulatory Strategy (GRS)(m/w/x)
Baar
Full-timeOn-siteSenior
Nejo AI Summary
Developing global regulatory strategies for oncology medicines, ensuring optimal labeling and approvals. Oncology Global Regulatory Affairs expertise required. Cross-functional team collaboration, matrix environment.
Requirements
- Bachelor’s degree in Biological or Healthcare Science
- Experience in all drug development phases
- Experience in Oncology Global Regulatory Affairs
- Expertise in leading global/regional development, submission, approval
- Knowledge of clinical trial and licensing requirements
- Ability to derive compliant solutions to regulatory challenges
- Strong written communication skills
- PhD in Biological or Healthcare Science
- Knowledge of oncology therapy areas
- Proficiency in digital fluency tools
Tasks
- Lead and execute regulatory strategies
- Ensure optimal labeling and approvals
- Maintain compliance with internal and external requirements
- Work in cross-functional and matrix environments
- Develop and implement global/regional regulatory strategy
- Align with Medicines Development Strategy and Integrated Asset Plan
- Collaborate with Early/Medicine Development Teams
- Work with Global Regulatory Lead
- Ensure robust regulatory strategies
- Manage interactions with regulatory authorities
- Handle reviews and submissions
- Collaborate with commercial teams
- Secure best possible labeling
- Assess regulatory intelligence
- Evaluate precedents and competitive landscape
- Inform strategy development
- Improve decision-making
- Ensure compliance with regulatory requirements
- Foster strong matrix working relationships
- Facilitate dialogue across teams
- Drive process improvement
- Promote innovation
- Enhance performance excellence
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- digital fluency tools
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of GlaxoSmithKline GmbH & Co. KG 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
GlaxoSmithKline GmbH & Co. KG
Industry
Pharmaceuticals
Description
GSK is a global biopharma company focused on innovative medicines and vaccines to improve health at scale.
Not a perfect match?
- Takeda Pharmaceuticals International AG
Associate Director, EUCAN Regulatory Lead - Oncology(m/w/x)
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Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Sanofi International AG
Head, Launch Acceleration & Regulatory Enablement - Global Launch Center(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz