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Director, Labelling Strategy and Governance

GSK
  • US
    Edgemont, South Dakota, United States
  • US
    Edgemont, South Dakota, United States

Über

Director, Global Regulatory Labelling Strategy And Governance

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

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 lifecyclefrom early development through lifecycle management.

In this role, you will line manage a small team of labelling professionals and collaborate closely with cross-functional partners across regulatory, clinical, safety, medical, and commercial functions. You will play a critical role in translating complex scientific data into effective product information and influencing labelling strategy at a global level.

This position offers high visibility, strategic impact, and the opportunity to help shape labelling practices that ultimately support patients worldwide.

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 (23 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.

Apply now If this role fits your experience and ambitions, we encourage you to apply. Tell us how you would lead labelling excellence and help improve outcomes for people.

  • Edgemont, South Dakota, United States

Sprachkenntnisse

  • English
Hinweis für Nutzer

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