Global Oncology Regulatory Strategy Director

NCBioImpact; Durham (NC); Hybrid; USD 172,000 - 286,000; Full time

Job summary

GSK seeks a Director, Global Regulatory Strategy- Oncology in the United States to lead regulatory strategies for oncology assets across development stages, coordinating with health authorities and cross-functional teams.

The role involves global regulatory leadership, strategic planning, and ensuring compliance with regulatory requirements and internal policies, with potential people leadership responsibilities.

Qualifications

• 8+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or healthcare industry.
• 6+ years of experience supporting drug development programs spanning multiple phases of clinical development.
• 3+ years of experience developing and executing global regulatory strategies for investigational or marketed products in Oncology.
• Experience leading Health Authority interactions, including preparation, execution, and follow-up activities related to regulatory milestone meetings.
• Experience working on cross-functional development teams, including Clinical, Safety, Commercial, Statistics, CMC, and other R&D functions.
• Experience assessing and applying regulatory precedent, regulatory intelligence, and evolving regulatory requirements to development or lifecycle management programs.
• Experience supporting regulatory activities in major global markets, including the United States, European Union, or other international regulatory jurisdictions.
• Experience influencing senior stakeholders and providing strategic regulatory recommendations in a matrix environment.
• Demonstrated experience ensuring compliance with applicable regulatory requirements, industry standards, and company policies throughout the product lifecycle.

Responsibilities

• Lead or oversee the development and execution of regulatory strategies for assigned assets, ensuring alignment with development plans and regulatory requirements.
• Provide regulatory leadership for assigned programs, including assessment of regulatory precedent and regulatory intelligence.
• Lead, coordinate, or contribute to interactions with health authorities and regulatory review processes.
• Work with cross-functional teams to support regulatory strategy and labeling objectives.
• Serve as a point of accountability for assigned regulatory work packages and lead regulatory matrix activities.
• Ensure regulatory activities comply with laws, regulations, and internal policies.
• Provide regulatory input into due diligence, business development, or portfolio-level assessments.

Skills

Regulatory strategy leadership

Stakeholder influence

Cross-functional collaboration

Regulatory intelligence

Regulatory communication

Team leadership

Education

Bachelor's degree in biology / related field

Advanced degree (MS, PharmD, PhD, MD) preferred

Tools

Job description

GSK seeks a Director, Global Regulatory Strategy- Oncology in the United States to lead regulatory strategies for oncology assets across development stages, coordinating with health authorities and cross-functional teams.

The role involves global regulatory leadership, strategic planning, and ensuring compliance with regulatory requirements and internal policies, with potential people leadership responsibilities.