Gsk
biopharma
AssociateDirector,GlobalRegulatoryStrategy(GRS)(m/f/d)
“Associate Director, Global Regulatory Strategy (GRS) (m/f/d) at Gsk. Skills: Lead and execute regulatory strategies for global and regional assets, Ensuring optimal labeling and approvals, Maintaining compliance with internal and external requirements. Develop and implement global/regional regulatory strategy for assigned assets in alignment with Medicines Development Strategy and Integrated Asset Plan. Work closely with Early/Medicine Development Teams (EDT/MDT) or Global Regulatory Lead (GRL) ”
What You'll Achieve.
Ensuring optimal labeling and approvals; Deliver project objectives across multiple regions; Secure the best possible labeling based on available data; Improve decision-making; Optimize outcomes
Industry & Context.
Ability to derive creative and compliant solutions to regulatory challenges while balancing agency expectations
What They're Looking For.
Must Have
Bachelor’s degree in Biological or Healthcare Science, Experience in all phases of drug development process, preferably in regulatory affairs, Experience in Oncology Global Regulatory Affairs, Proven expertise in leading global and regional development, submission, and approval activities, Comprehensive knowledge of clinical trial and licensing requirements across major regional/global markets, Ability to derive creative and compliant solutions to regulatory challenges while balancing agency expectations, communication skills, particularly in writing, with clarity and impact
Nice to Have
PhD in Biological or Healthcare Science, Demonstrated knowledge of oncology therapy areas and ability to develop specialist knowledge of assigned assets, Proficiency in digital fluency tools to enhance project delivery, efficiency, and innovation
What You'll Do.
Develop and implement global/regional regulatory strategy for assigned assets in alignment with Medicines Development Strategy and Integrated Asset Plan
Work closely with Early/Medicine Development Teams (EDT/MDT) or Global Regulatory Lead (GRL) to ensure robust regulatory strategies that meet key market requirements
and submissions with regional/local regulatory authorities for product development and approval
Collaborate with commercial teams in the local region to secure the best possible labeling based on available data
Assess regulatory intelligence
and competitive landscape to inform strategy development and improve decision-making
Ensure compliance with global
and local regulatory requirements throughout the product lifecycle
Drive process improvement
and performance excellence through the development and implementation of strategic changes
How You'll Work.
Team & Collaboration
Work in cross-functional and matrix environments to deliver project objectives across multiple regions; Foster matrix working relationships within GSK (to VP level) and facilitate dialogue across teams to optimize outcomes
Communication Scope
communication skills, particularly in writing, with clarity and impact
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