Hybrid Global Oncology Regulatory Manager

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

Benefits offered by this job

Annual bonus

Healthcare

Pension plan

Share-based long term incentive

Job summary

GlaxoSmithKline is seeking a Global Regulatory Affairs Manager in Oncology to lead global/regional regulatory strategies for oncology assets, ensuring compliant labeling and timely approvals across multiple regions. You will collaborate with GRL and TA Head and cross-functional teams to shape development plans and regulatory interactions, prioritizing patient outcomes.

The role emphasizes strategic thinking, cross-functional partnership and the ability to navigate complex regulatory landscapes,

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+ years 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 align regulatory plans with development strategies.
• Support interactions with regulatory authorities for product development and approval.
• Assess regulatory intelligence and precedents to inform strategy decisions.
• Ensure compliance with global, regional, and local regulatory requirements throughout the product lifecycle.
• Drive process improvements and strategic changes within regulatory constraints.

Skills

Regulatory strategies

Cross-functional collaboration

Digital fluency

Regulatory compliance

Project management

Education

Bachelor's degree (bio/pharma)

Job description

GlaxoSmithKline is seeking a Global Regulatory Affairs Manager in Oncology to lead global/regional regulatory strategies for oncology assets, ensuring compliant labeling and timely approvals across multiple regions. You will collaborate with GRL and TA Head and cross-functional teams to shape development plans and regulatory interactions, prioritizing patient outcomes.

The role emphasizes strategic thinking, cross-functional partnership and the ability to navigate complex regulatory landscapes,