About this opportunity
Valtera Group Ltd lists this Regulatory Affairs Consultant opportunity in city of cedar rapids, Iowa. Review the employer’s description below for duties, qualifications and application requirements.
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
Worksite address
city of cedar rapids, IA, 52404, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.