Job Description

Global Labeling Strategy Lead (Contract)

Global Pharmaceutical Company EST timezone (remote) - US-based Full-time | 6‑month contract Competitive hourly rate Start: ASAP

The Opportunity A global pharmaceutical organisation is seeking an

experienced, senior labelling leader

to take end‑to‑end ownership of global product labelling across a defined portfolio. This is a

hands‑on leadership role

with genuine accountability, not a support- or execution-only position. You will serve as the

global steward for core and major‑market labelling , translating data into claims, guiding lifecycle decisions, and balancing regulatory risk with commercial objectives.

Key Responsibilities Global Labelling Ownership Own and maintain

global Core Data Sheets (CCDS)

and associated patient information Lead translation of global data into

major‑market labels

(e.g. US PI, EU SmPC) Manage global vs local deviations and support Health Authority interactions Lead complex labelling updates across the product lifecycle

Strategy & Lifecycle Input Develop and maintain

Target Product Labelling (TPL)

to support development and regulatory positioning Conduct

competitive labelling analyses

and regulatory precedent assessments Provide labelling input to global regulatory strategy and major submissions

Candidate Profile Experience 7–10+ years’ experience in Regulatory Affairs with

significant global labelling responsibility Proven ownership of

CCDS and major‑market labels

(US and EU) Experience supporting regulatory submissions in key markets Strong background in

TPL development

and lifecycle labelling strategy

Job Tags

Hourly pay, Full time, Contract work, Local area, Immediate start, Remote work

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