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
Regulatory Affairs Consultant in baltimore at Unknown Company
This position is listed as contract and able to be worked remotely.