Director, Labelling Strategy and Governance

About the role

Position Summary: As Director, Global Regulatory Labelling Strategy and Governance, you will lead the strategy and execution of product labelling for assigned assets within GSK’s vaccines and infectious diseases portfolio. You will oversee the development of clear, compliant, and patient-focused labelling across the product lifecycle—from early development through lifecycle management.

Key Responsibilities:

• Lead global labelling strategy and execution for assigned assets across development and lifecycle stages.
• Line manage, coach, and develop a small team of global labelling professionals, building capability and engagement.
• Translate clinical and safety data into clear, compliant, and patient-focused labelling content.
• Partner with cross-functional teams (regulatory, clinical, safety, medical, and commercial) to align on labelling strategy and deliverables.
• Represent the portfolio in labelling governance bodies and ensure alignment with global regulatory requirements and internal standards.
• Provide strategic labelling guidance to project teams and senior stakeholders, including implications for development plans and regulatory submissions.
• Engage with health authorities, external stakeholders, and professional organizations to support regulatory interactions and contribute to the evolution of labelling practices.

Requirements

Basic Qualifications:

• Bachelor’s degree in life sciences, pharmacy, medicine, or a related discipline.
• 5+ years of labelling or regulatory experience within the pharmaceutical or biotechnology industry.
• Demonstrated experience leading global and regional labelling strategy (US PI, EU SmPC) for pharmaceutical products.

Preferred Qualifications:

• Advanced degree (MS, PharmD, MD, or PhD) in a relevant scientific discipline.
• Experience line managing and developing teams within labelling or regulatory functions.
• Direct experience engaging with health authorities and supporting regulatory submissions.
• Experience in vaccines, infectious diseases, or related therapeutic areas.
• Experience working in cross-functional, matrixed organizations.
• Proven ability to interpret clinical and safety data and translate it into regulatory-compliant labelling.
• Strong written and verbal communication skills, with experience presenting to senior stakeholders.
Qualifications
• Bachelor’s degree in life sciences, pharmacy, medicine, or a related discipline.
• 5+ years of labelling or regulatory experience within the pharmaceutical or biotechnology industry.
• Advanced degree (MS, PharmD, MD, or PhD) in a relevant scientific discipline.
• Direct experience engaging with health authorities and supporting regulatory submissions.
• Experience in vaccines, infectious diseases, or related therapeutic areas.
• Experience working in cross-functional, matrixed organizations.
• Proven ability to interpret clinical and safety data and translate it into regulatory-compliant labelling.
• Strong written and verbal communication skills, with experience presenting to senior stakeholders.