Labelling Strategy and Development, Oncology Team Lead

Role Summary

As a therapeutic head within Labelling Strategy and Governance, you will lead a global labelling team for oncology products. You will engage with key stakeholders across R&D to ensure effective development of GSK oncology labels. You will shape labelling that is clear, compliant, and supports patient care and product success. This role offers visible impact, professional growth, and the chance to help GSK unite science, technology and talent to get ahead of disease together. Location: USA - Pennsylvania - Upper Providence; Belgium-Wavre; Durham Blackwell Street; Italy - Siena; UK – London – New Oxford Street.

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 (e.g., related to product information, submission strategy) and work with matrix teams to resolve issues in a proactive manner.
• Provide strategic direction for labelling governance issues for 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 to develop, implement, and maintain policies and standards.
• Engage with Regulatory Authorities in areas impacting labelling standards and policies directly or collectively through professional organizations to drive innovative labelling approaches.

Qualifications

• Required: Bachelor's degree in life sciences, pharmacy, medicine, or related field.
• Required: At least 5 years of regulatory affairs or labelling experience in the pharmaceutical or biotech industry with line and matrix leadership experience
• Required: 3+ years of experience leading global labelling development, submissions, or regulatory interactions.
• Preferred: Advanced degree (MS, PharmD, MD, or PhD) in a relevant scientific discipline.
• Preferred: Experience in oncology therapeutic areas and familiarity with oncology clinical data and endpoints.
• Preferred: Prior direct experience interacting with regulatory reviewers.
• Preferred: Experience aligning labelling strategy with commercial and medical affairs objectives.
• Preferred: Track record of developing patient-focused labeling and plain-language content.
• Preferred: Experience mentoring colleagues and building capability within a labelling or regulatory team.
• Preferred: Strong knowledge of regulatory requirements for prescription product labelling and safety reporting.
• Preferred: Proven ability to lead cross-functional teams and manage complex review processes and timelines.
• Preferred: Clear written and verbal communication skills, with experience drafting regulatory documents and communicating with regulators.

Additional Requirements

• Work arrangement: Hybrid with regular on-site collaboration; typical schedule will be 2 to 3 days on-site per week.