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. In this role you will line‑manage a small team of labelling professionals, collaborate closely with cross‑functional partners across regulatory, clinical, safety, medical, and commercial functions, and translate complex scientific data into effective product information that shapes labelling practices with global impact. 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.
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. Willingness and ability to work in a hybrid environment with regular onsite collaboration (2–3 days per week). Demonstrated ability to develop clear, patient‑friendly, plain‑language labelling content. Strong written and verbal communication skills, with experience presenting to senior stakeholders.
Compensation and Benefits Salary ranges: Italy €86,250 – €143,750; Belgium €111,750 – €186,250. Additional information on benefits (annual bonus, share‑based incentives) will be provided during recruitment. GSK is an Equal Opportunity Employer. Applications are accepted from multiple locations. Please contact recruitment staff for accommodations. #J-18808-Ljbffr