Director – Labelling Strategy and Governance

GSK

Director leading global regulatory labelling strategy for GSK's vaccine portfolio. Overseeing product labelling execution and managing a team of professionals.

Posted 6/6/2026full-timeUpper Providence • Pennsylvania • 🇺🇸 United StatesLead💰 €86,250 - €143,750 per yearWebsite

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Hard Skills

labelling strategyregulatory submissionsclinical data interpretationsafety data interpretationcompliant labelling contentteam managementproject managementglobal regulatory requirementsUS PIEU SmPC

Soft Skills

leadershipcoachingteam developmentcross-functional collaborationstrategic guidancestakeholder engagementcommunicationcapability buildingengagementalignment

Certifications & Qualifications

Bachelor’s degreeMSPharmDMDPhD

Industry Keywords

pharmaceutical industrybiotechnology industryvaccinesinfectious diseasesregulatory compliancelabelling governancehealth authoritiesclinical trialspatient-focused labellingtherapeutic areas

About the role

Key responsibilities & impact

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

What you’ll need

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
Advanced degree (MS, PharmD, MD, or PhD) in a relevant scientific discipline (preferred)
Experience line managing and developing teams within labelling or regulatory functions (preferred)
Direct experience engaging with health authorities and supporting regulatory submissions (preferred)
Experience in vaccines, infectious diseases, or related therapeutic areas (preferred)
Proven ability to interpret clinical and safety data and translate it into regulatory-compliant labelling.

Benefits

Comp & perks

Annual bonus
Participation in share based long term incentive program
Comprehensive benefits package