Senior Regulatory Affairs Associate- Labeling Strategy
Core
Develop and manage global labeling strategies and compliant labeling documents for new treatments to ensure regulatory compliance across major markets.
Role type
Senior Regulatory Affairs Associate (Labeling Strategy)
Builds
Global labeling documents, artwork, and regulatory submissions for pharmaceutical therapies
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Required skills
Global labeling strategy, regulatory compliance, post-approval labeling management, Regulatory Impact Assessments, artwork approval coordination, SPL proficiency, document management systems, comparator labeling research, Annual Reports authoring, stakeholder liaison
Preferred skills
Advanced degree in Regulatory Affairs, regulatory information management systems (Veeva, TVT, Docubridge), advertising and promotion regulations, multi-therapeutic area experience
Technologies
SPL, Document Management Systems, Artwork Trackers, xEVMPD, PSUR systems
Responsibilities
Develop and maintain global labeling documents (CCDS, USPI, regional labels); Manage post-approval labeling activities (artwork updates, safety variations, xEVMPD, PSURs); Conduct Regulatory Impact Assessments for change controls; Coordinate artwork approval processes; Manage artwork change requests and operational processes; Research comparator labeling documents; Author labeling components of Annual Reports; Liaise with internal and external stakeholders for labeling changes
Seniority
Senior, hands-on IC