Senior Manager, Labelling Strategy and Development

Overview

Site Name: USA - Pennsylvania - Upper Providence

Posted Date: Jan 21 2026

Job Purpose: Accountable to drive and deliver US Product Information (PI) (including healthcare professional and patient information) for Established Products (EP) in compliance with internal and external standards, processes and policies. Interface directly with all GSK functional experts who contribute data for US Prescribing Information and ensure compliance with GSK Regulatory Submission processes. The role may include some global labelling responsibilities.

This is a hybrid role based at our Upper Providence site in Collegeville, PA requiring 2-3 days on-site per week average.

• Authors healthcare professional and patient information for assigned products for the US market and ensures compliance with US Local Labelling processes including submission of Country Labelling Differences.
• Develops high quality USPI and associated strategy for EP products by providing local regulatory advice and expertise regarding US prescribing and patient information requirements, precedents, and competitor labelling.
• Authors responses to labelling questions from the FDA.
• Ensures effective communication within Labelling Strategy and Governance, and with other GSK labelling groups (e.g., Global Labelling Operations and Regulatory Therapeutic Group) regarding issues which may impact other GSK products.
• Makes well thought out, efficient decisions, with some guidance from Line Manager, based on pertinent facts, relevant information, risk assessment and good judgment with respect to the compliance of healthcare professional and patient information with reference to GSK internal standards, and US regulatory requirements.
• Works flexibly but within the limitations of internal and external requirements to facilitate risk mitigation within project teams, such as anticipating regulators’ questions regarding data, format, or content.
• Demonstrates knowledge of relevant US regulations and guidances, and adapts to changes in regulatory requirements and internal standards as required.
• In conjunction with the GRA Regional Director, represents GSK at label meetings with FDA.

Basic Qualifications:

• Bachelor’s Degree in Life Sciences related discipline
• 8 plus years  experience in pharmaceutical regulatory affairs
• 4 plus years in a labelling-focused role in a matrixed environment
• Experience authoring or contributing to core US labelling documents (e.g. USPI, patient information)
• Experience with cross-functional labeling reviews involving Regulatory, Medical Affairs, Safety/Pharmacovigilance, Legal, CMC and Commercial teams

Preferred Qualifications:

• MS, Pharm
  
  D, PhD
• Developed interpersonal, presentation and communication skills
• Influences effectively in a matrix environment
• Recognizes key issues which require escalation
• Runs efficient meetings
• Demonstrates an understanding of company priorities and responds appropriately and flexibly to ensure deadlines are met successfully

Additional information:
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health  aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.

Our culture is built on ambition for patients, accountability for impact and doing the right thing.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at  where you can also request a call. If your inquiry does not relate to adjustments, we will not be able to support you through these channels. We have created a Recruitment FAQ guide with answers to multiple questions we receive.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal…