Global Head, Oncology Regulatory Labelling & Strategy

Glaxosmithkline; Rockville (MD); Hybrid; USD 222,000 - 370,000; Full time

Benefits offered by this job

Annual bonus

Long-term share-based incentive

Health insurance and family benefits

Retirement benefits

Paid holidays and vacation

Parental and medical leave

Job summary

GSK is seeking a Sr Director and Team Lead for Regulatory Labelling Strategy and Development in Oncology. You will lead a global team, shape compliant and patient-focused labelling, and partner with R&D, Safety, Regulatory, and Commercial to align strategies.

The role offers hybrid work with on-site collaboration and opportunities to influence labeling standards, timelines, and regulatory submissions across therapeutic areas.

Qualifications

• Bachelor's degree in life sciences, pharmacy, medicine, or related field.
• Advanced degree (MS, PharmD, MD, or PhD) in a relevant scientific discipline.
• Experience leading global labelling development and regulatory interactions.

Responsibilities

• Manage, train, and motivate a team of global labelling professionals for the oncology portfolio.
• Accountable for management of the labelling process from development through early lifecycle management.
• Ensure compliance with regulatory requirements and collaborate with matrix teams to resolve issues.
• Provide strategic direction for labelling governance issues and serve on Global Labelling Committee.
• Advise Regulatory and senior management on labelling issues across R&D, Safety, Regulatory and Commercial.
• Engage with Regulatory Authorities to drive innovative labelling approaches.

Skills

Business resilience

Communication

Digital fluency

Matrix leadership

Pharmaceutical regulatory compliance

Policy advocacy

Regulatory strategies

Resource management

Stakeholder management

Education

Bachelor's degree in life sciences, pharmacy, medicine, or related field

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

Job description

GSK is seeking a Sr Director and Team Lead for Regulatory Labelling Strategy and Development in Oncology. You will lead a global team, shape compliant and patient-focused labelling, and partner with R&D, Safety, Regulatory, and Commercial to align strategies.

The role offers hybrid work with on-site collaboration and opportunities to influence labeling standards, timelines, and regulatory submissions across therapeutic areas.