Global Oncology Regulatory Affairs Manager (Hybrid)

GlaxoSmithKline; Waltham (MA); Hybrid; USD 139,000 - 231,000; Full time

Benefits offered by this job

Annual bonus

Shares and savings programme

Healthcare and wellbeing programs

Pension plan

Job summary

GlaxoSmithKline seeks a Global Regulatory Affairs Manager for Oncology to lead regulatory strategies across multiple regions and ensure compliant labeling and approvals. You will work with GRL and TA Head, guiding cross-functional teams and shaping development plans to accelerate oncology assets.

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

Qualifications

• Bachelor's degree in biological, pharmaceutical or healthcare science.
• 1+ year of experience in drug development process, preferably in regulatory affairs and oncology.
• 1+ year of experience in clinical trial requirements in at least one major regional/global market.

Responsibilities

• Develop and execute global/regional regulatory strategies for oncology assets.
• Collaborate with cross-functional teams to shape development plans and regulatory interactions.
• Ensure compliance with global, regional, and local regulatory requirements across lifecycle.
• Support submissions with regional/local authorities and assess regulatory intelligence.
• Drive improvements and innovative solutions within regulatory constraints.
• Lead activities to progress career growth and development.

Education

Bachelor's degree in biological/pharmaceutical/healthcare science

Advanced scientific degree (PhD, MD, PharmD)

Job description

GlaxoSmithKline seeks a Global Regulatory Affairs Manager for Oncology to lead regulatory strategies across multiple regions and ensure compliant labeling and approvals. You will work with GRL and TA Head, guiding cross-functional teams and shaping development plans to accelerate oncology assets.

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