Director, Global Regulatory Affairs Lead (Oncology)
GSK
August 15, 2026
Remote friendly (Collegeville, PA)
United States
Corporate Functions
Director, Global Regulatory Strategy – Oncology
Key Responsibilities:
- Lead or oversee the development and execution of regulatory strategies for assigned assets, aligned with development plans, integrated evidence strategies, priority market needs, and applicable regulatory requirements.
- Provide regulatory leadership for assigned programs (regulatory precedent, regulatory intelligence, competitive landscape, and impact on asset strategy).
- Lead, coordinate, or contribute to interactions with health authorities and regulatory review processes.
- Partner with Early Development, Medicine Development, local regulatory teams, commercial partners, and cross-functional stakeholders to support regulatory strategy and labeling objectives consistent with available data.
- Accountable for assigned regulatory work packages and lead/contribute to Regulatory Matrix Team activities (as applicable).
- Ensure regulatory activities comply with applicable laws, regulations, internal policies, and GSK expectations.
- Provide regulatory input into due diligence, business development, or portfolio-level assessments (as needed).
- (If people leadership) Manage and develop team members, support workforce and resource planning, and build effective inclusive teams.
- Partner with senior stakeholders on program strategy, resource planning, operating model development, and long-term objectives.
- Communicate regulatory strategy, risks, options, and recommendations to senior leaders, health authorities, and cross-functional partners.
Required Qualifications:
- Bachelor’s degree in biology/Life Sciences/Healthcare Sciences/Pharmaceutical Sciences/Regulatory Science or related.
- 8+ years Regulatory Affairs experience in pharma/biotech/healthcare.
- 6+ years supporting multi-phase clinical drug development programs.
- 3+ years developing/executing global oncology regulatory strategies for investigational or marketed products.
- Experience leading Health Authority interactions (preparation, execution, follow-up for regulatory milestones).
- Cross-functional team experience (Clinical, Safety, Commercial, Statistics, CMC, R&D).
- Experience applying regulatory precedent, intelligence, and evolving requirements to development/lifecycle programs.
- Experience across major markets (US, EU, or other international).
- Experience influencing senior stakeholders in a matrix environment.
- Demonstrated compliance experience across product lifecycle.
Preferred Qualifications:
- Advanced degree (MS/PharmD/PhD/MD or equivalent).
- 10+ years Regulatory Affairs experience.
- Experience in business development, licensing, acquisitions, or due diligence.
- Experience leading across multiple geographic regions.
- Experience managing regulatory professionals in a global matrix.
- Experience using digital/AI/data-driven approaches in regulatory strategy.
Work Arrangement:
- Hybrid; regular presence at a US site for leadership activities and key meetings. Remote-first candidates may be considered if in the US and able to travel as required.
Skills:
- Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Regulatory Strategies, Resource Management, Stakeholder Management.
Key Responsibilities:
- Lead or oversee the development and execution of regulatory strategies for assigned assets, aligned with development plans, integrated evidence strategies, priority market needs, and applicable regulatory requirements.
- Provide regulatory leadership for assigned programs (regulatory precedent, regulatory intelligence, competitive landscape, and impact on asset strategy).
- Lead, coordinate, or contribute to interactions with health authorities and regulatory review processes.
- Partner with Early Development, Medicine Development, local regulatory teams, commercial partners, and cross-functional stakeholders to support regulatory strategy and labeling objectives consistent with available data.
- Accountable for assigned regulatory work packages and lead/contribute to Regulatory Matrix Team activities (as applicable).
- Ensure regulatory activities comply with applicable laws, regulations, internal policies, and GSK expectations.
- Provide regulatory input into due diligence, business development, or portfolio-level assessments (as needed).
- (If people leadership) Manage and develop team members, support workforce and resource planning, and build effective inclusive teams.
- Partner with senior stakeholders on program strategy, resource planning, operating model development, and long-term objectives.
- Communicate regulatory strategy, risks, options, and recommendations to senior leaders, health authorities, and cross-functional partners.
Required Qualifications:
- Bachelor’s degree in biology/Life Sciences/Healthcare Sciences/Pharmaceutical Sciences/Regulatory Science or related.
- 8+ years Regulatory Affairs experience in pharma/biotech/healthcare.
- 6+ years supporting multi-phase clinical drug development programs.
- 3+ years developing/executing global oncology regulatory strategies for investigational or marketed products.
- Experience leading Health Authority interactions (preparation, execution, follow-up for regulatory milestones).
- Cross-functional team experience (Clinical, Safety, Commercial, Statistics, CMC, R&D).
- Experience applying regulatory precedent, intelligence, and evolving requirements to development/lifecycle programs.
- Experience across major markets (US, EU, or other international).
- Experience influencing senior stakeholders in a matrix environment.
- Demonstrated compliance experience across product lifecycle.
Preferred Qualifications:
- Advanced degree (MS/PharmD/PhD/MD or equivalent).
- 10+ years Regulatory Affairs experience.
- Experience in business development, licensing, acquisitions, or due diligence.
- Experience leading across multiple geographic regions.
- Experience managing regulatory professionals in a global matrix.
- Experience using digital/AI/data-driven approaches in regulatory strategy.
Work Arrangement:
- Hybrid; regular presence at a US site for leadership activities and key meetings. Remote-first candidates may be considered if in the US and able to travel as required.
Skills:
- Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Regulatory Strategies, Resource Management, Stakeholder Management.