GSK · 11 hours ago
Senior Manager, Labelling Strategy and Development
Collegeville, PA
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expGSK is a global biopharma company aiming to unite science, technology and talent to get ahead of disease together. They are seeking a Senior Manager for Labelling Strategy and Development to drive and deliver US Product Information for Established Products in compliance with internal and external standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
Qualification
Required
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
MS, PharmD, 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
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
2026-01-16
2026-01-13
South China Morning Post
2026-01-08
Company data provided by crunchbase