Regulatory Affairs Consultant
valtera groupBaltimore, MD
Regulatory Affairs Consultant
valtera groupBaltimore, MDManager L7
Pharmaceutical Preparation ManufacturingBiological Product (except Diagnostic) ManufacturingOther Scientific and Technical Consulting Services
APPLY NOWGlobal Labeling Strategy Lead (Contract) Global Pharmaceutical Company📍 EST timezone (remote) - US-based🕒 Full-time | 6‑month contract💰 Competitive hourly rate🚀 Start: ASAPThe 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:
- Experience7–10+ 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
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Level
Manager L7
Location
Baltimore, MD
Occupation
Regulatory Affairs Managers
Industry
Pharmaceutical Preparation Manufacturing
Posted
yesterday