Regulatory Affairs Consultant (Washington DC-Baltimore Area)

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