GSK

Executive Director – Strategic Labelling

GSK

full-time

Posted on:

Location Type: Hybrid

Location: Upper ProvidencePennsylvaniaUnited States

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Salary

💰 $221,925 - $369,875 per year

Job Level

About the role

  • Lead the global labelling process for GSK’s development portfolio through early lifecycle stages.
  • Ensure regulatory requirements related to product information and submission strategies are met, proactively resolving issues across therapy areas.
  • Provide strategic direction for labelling governance and represent GSK in global labelling committees and industry events.
  • Advise senior management and regulatory teams on product labelling policies, standards, and compliance.
  • Manage and motivate the Strategic Labelling team (including team leaders and their teams), fostering collaboration and alignment with GSK’s principles.
  • Represent GSK in industry groups and during internal and external regulatory inspections or audits related to labelling governance and processes.

Requirements

  • Bachelor's degree in Science, Medicine, or Pharmacy
  • Regulatory experience across all phases of the drug development process in a global pharmaceutical company
  • Global labelling experience
  • People management and matrix leadership experience
  • Advanced degree (MS, PharmD, PhD) in Science, Medicine, or Pharmacy (preferred)
  • Regulatory Affairs strategy experience, preferably in a leadership role (preferred)
  • Deep understanding of multi-regional external regulatory environments (preferred)
  • Proven ability to rapidly assimilate data and resolve complex problems, making recommendations to senior management (preferred)
  • Proven ability to lead global teams, resolve complex regulatory and scientific issues, and influence effectively in a matrix environment (preferred)
  • Strong interpersonal, presentation, and communication skills with established internal and external networks (preferred)
Benefits
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Applicant Tracking System Keywords

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Hard Skills & Tools
regulatory experienceglobal labelling experienceregulatory affairs strategydrug development processcompliance standardsdata assimilationproblem resolution
Soft Skills
people managementmatrix leadershipstrategic directioncollaborationinfluencepresentation skillscommunication skills
Certifications
Bachelor's degree in ScienceBachelor's degree in MedicineBachelor's degree in PharmacyMSPharmDPhD