Oncology Global Regulatory Lead

GlaxoSmithKline; Upper Providence (Delaware County); Hybrid; USD 139.000 - 231.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Healthcare

Pension plan

Shares and savings programme

Zusammenfassung

GlaxoSmithKline is seeking a Global Regulatory Affairs Manager, Oncology, to lead regulatory strategies for oncology assets across multiple regions. You will work with GRL and TA Head to align plans with development strategies, ensuring timely submissions and robust regulatory interactions.

The role emphasizes collaboration, problem solving, and a patient-first mindset, with a hybrid work model and a strong benefits program.

Qualifikationen

• Bachelor's degree in biological, pharmaceutical or healthcare science.
• 1+ year of experience in drug development regulatory affairs and oncology.
• 1+ year of experience with clinical trial requirements in major markets.

Aufgaben

• Develop and execute global/regional regulatory strategies for oncology assets.
• Ensure labeling and approvals meet regulatory requirements across regions.
• Collaborate with cross-functional teams to shape development plans and regulatory interactions.
• Support interactions with regional authorities for product development and approval.
• Assess regulatory intelligence to inform strategy and decision-making.
• Drive compliance throughout the product lifecycle and promote process improvements.

Kenntnisse

Business Resilience

Communication

Digital Fluency

Matrix Leadership

Pharmaceutical Regulatory Compliance

Regulatory Strategies

Resource Management

Stakeholder Management

Ausbildung

Bachelor's degree in biological, pharmaceutical or healthcare science

Advanced scientific degree (PhD, MD, PharmD)

Jobbeschreibung

GlaxoSmithKline is seeking a Global Regulatory Affairs Manager, Oncology, to lead regulatory strategies for oncology assets across multiple regions. You will work with GRL and TA Head to align plans with development strategies, ensuring timely submissions and robust regulatory interactions.

The role emphasizes collaboration, problem solving, and a patient-first mindset, with a hybrid work model and a strong benefits program.