Global Oncology Regulatory Strategy Lead

GlaxoSmithKline plc; Upper Providence (Delaware County); Hybrid; USD 172,000 - 286,000; Full time

Job summary

GlaxoSmithKline plc in the United States seeks a Director of Global Regulatory Strategy – Oncology to lead regulatory planning and execution for prioritized assets, aligning development plans with global requirements and internal policies.

You will partner with Early Development Teams and Health Authorities, mentor team members, and communicate strategic options to senior leaders. The role is hybrid, requiring regular on-site presence for leadership activities.

Qualifications

• Bachelor's degree in biology or related scientific field.
• 8+ years in Regulatory Affairs in pharma/biotech/healthcare.
• 6+ years supporting drug development programs across multiple phases.
• 3+ years developing and executing global regulatory strategies for oncology.
• Experience leading Health Authority interactions and follow-up activities.
• Experience working with cross-functional development teams (Clinical, Safety, Commercial, Statistics, CMC).
• Experience in major global markets including US/EU or other jurisdictions.
• Ability to influence senior stakeholders in a matrix environment and ensure lifecycle compliance.

Responsibilities

• Lead development and execution of regulatory strategies for assigned assets, aligning with development plans and data.
• Provide regulatory leadership and assess regulatory precedent, intelligence, and competitive landscape.
• Lead or contribute to interactions with health authorities and regulatory reviews as applicable.
• Coordinate with Early Development Teams, Medicine Development Teams, local regulatory teams, and cross-functional partners.
• Ensure regulatory activities comply with laws, policies, and GSK expectations.
• Lead team members, workforce planning, and resource management.

Skills

Regulatory strategy

Health Authority liaison

Cross-functional leadership

Regulatory intelligence

Strategic advisory

Regulatory compliance

Education

Bachelor's degree in Biology or related field

Advanced degree (MS/PhD/MD) preferred

Job description

GlaxoSmithKline plc in the United States seeks a Director of Global Regulatory Strategy – Oncology to lead regulatory planning and execution for prioritized assets, aligning development plans with global requirements and internal policies.

You will partner with Early Development Teams and Health Authorities, mentor team members, and communicate strategic options to senior leaders. The role is hybrid, requiring regular on-site presence for leadership activities.