Global Head of Oncology Regulatory Labelling & Strategy

Glaxosmithkline; Upper Providence (Delaware County); Hybrid; USD 222,000 - 370,000; Full time

Benefits offered by this job

Health care benefits

Retirement benefits

Paid holidays

Vacation

Parental and medical leave

Share-based long term incentive

Job summary

GSK is seeking a Sr Director and Team Lead in Regulatory Labelling Strategy and Development for Oncology. You will lead a global team to shape clear, compliant labelling that supports patient care and product success, interfacing with R&D, Safety, and Regulatory across regions.

You will guide strategy, governance, and regulatory interactions, mentoring colleagues and partnering with commercial and medical affairs to align labelling with business objectives.

Qualifications

• Bachelor's degree in life sciences, pharmacy, medicine, or related field.
• At least 5 years of regulatory affairs or labelling experience in the pharmaceutical or biotech industry with line and matrix leadership experience.
• 3+ years of experience leading global labelling development, submissions, or regulatory interactions.

Responsibilities

• Manage, train, and motivate a team of global labelling professionals for the oncology portfolio.
• Accountable for management of the GSK labelling process for the development portfolio from early development through to early lifecycle management.
• Ensure compliance with regulatory requirements and work with matrix teams to resolve issues proactively.
• Provide strategic direction for labelling governance issues for the assigned therapeutic area and serve on Global Labelling Committee.
• Advise Regulatory and senior management on issues relating to product labelling, interfacing with senior leaders across R&D, Safety, Regulatory and Commercial.
• Engage with Regulatory Authorities in areas impacting labelling standards and policies directly or collectively through professional organizations 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

Job description

GSK is seeking a Sr Director and Team Lead in Regulatory Labelling Strategy and Development for Oncology. You will lead a global team to shape clear, compliant labelling that supports patient care and product success, interfacing with R&D, Safety, and Regulatory across regions.

You will guide strategy, governance, and regulatory interactions, mentoring colleagues and partnering with commercial and medical affairs to align labelling with business objectives.