Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology

Position 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.

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.

Basic 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.

Preferred Qualifications

• Advanced degree (MS, PharmD, MD, or PhD) in a relevant scientific discipline.
• Experience in oncology therapeutic areas and familiarity with oncology clinical data and endpoints.
• Prior direct experience interacting with regulatory reviewers.
• Experience aligning labelling strategy with commercial and medical affairs objectives.
• Track record of developing patient-focused labeling and plain-language content.
• Experience mentoring colleagues and building capability within a labelling or regulatory team.
• Strong knowledge of regulatory requirements for prescription product labelling and safety reporting.
• Proven ability to lead cross-functional teams and manage complex review processes and timelines.
• Clear written and verbal communication skills, with experience drafting regulatory documents and communicating with regulators.

Work Arrangement

This role is hybrid with regular on-site collaboration expected. Typical schedule will be 2 to 3 days on-site per week.