Regulatory Affairs Consultant

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

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• Own and maintain global Core Data Sheets (CCDS) and associated patient information
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• Lead translation of global data into major‑market labels (e.g. US PI, EU SmPC)
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• Manage global vs local deviations and support Health Authority interactions
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• Lead complex labelling updates across the product lifecycle
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Strategy & Lifecycle Input

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• Develop and maintain Target Product Labelling (TPL) to support development and regulatory positioning
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• Conduct competitive labelling analyses and regulatory precedent assessments
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• Provide labelling input to global regulatory strategy and major submissions
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Candidate Profile

Experience

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• 7–10+ years’ experience in Regulatory Affairs with significant global labelling responsibility
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• Proven ownership of CCDS and major‑market labels (US and EU)
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• Experience supporting regulatory submissions in key markets
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• Strong background in TPL development and lifecycle labelling strategy
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