Dein persönlicher KI-Karriere-Agent
Associate Director, Global Regulatory Strategy (GRS)(m/w/x)
Developing global regulatory strategies for oncology medicines, ensuring optimal labeling and approvals. Oncology Global Regulatory Affairs expertise required. Cross-functional team collaboration, matrix environment.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- digital fluency tools
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Associate Director, Global Regulatory Strategy (GRS)(m/w/x)
Developing global regulatory strategies for oncology medicines, ensuring optimal labeling and approvals. Oncology Global Regulatory Affairs expertise required. Cross-functional team collaboration, matrix environment.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- digital fluency tools
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
GlaxoSmithKline GmbH & Co. KG
Branche
Pharmaceuticals
Beschreibung
GSK is a global biopharma company focused on innovative medicines and vaccines to improve health at scale.
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