Global Oncology Regulatory Manager

GSK plc; Durham (NC); Hybrid; USD 139,000 - 231,000; Full time

Benefits offered by this job

Healthcare benefits

Pension plan

Share incentive program

Annual bonus

Job summary

GSK plc in the United States is seeking a Global Regulatory Affairs Manager in Oncology to lead global and regional regulatory strategies for oncology assets, ensuring robust labeling and timely approvals while upholding compliance.

You will collaborate with cross-functional teams, report to the Global Regulatory Lead and Therapeutic Area Head, and drive strategic changes across regions, aligning with Medicines Development Strategy and Integrated Asset Plans.

Qualifications

• Minimum: Bachelor's degree in biological, pharmaceutical or healthcare science.
• 1+ year of experience in drug development process, preferably in regulatory affairs and oncology.
• Advanced degree (PhD, MD, PharmD) preferred.
• Experience leading global/regional regulatory activities and working in oncology.

Responsibilities

• Develop and execute global/regional regulatory strategies for oncology assets.
• Ensure optimal labeling and approvals while maintaining compliance.
• Collaborate with cross-functional teams to shape development plans and regulatory interactions.
• Support interactions, reviews, and submissions with regulatory authorities.
• Drive process improvements and strategic changes across regions.

Skills

Business Resilience

Communication

Digital Fluency

Matrix Leadership

Regulatory Compliance

Regulatory Strategies

Resource Management

Stakeholder Management

Education

Bachelor's degree in biological, pharmaceutical or healthcare science

Advanced scientific degree (PhD, MD, PharmD)

Job description

GSK plc in the United States is seeking a Global Regulatory Affairs Manager in Oncology to lead global and regional regulatory strategies for oncology assets, ensuring robust labeling and timely approvals while upholding compliance.

You will collaborate with cross-functional teams, report to the Global Regulatory Lead and Therapeutic Area Head, and drive strategic changes across regions, aligning with Medicines Development Strategy and Integrated Asset Plans.