US-NJ, Sr Global Regulatory Labeling Manager 220482BR-MZ
Sr Global Regulatory Labeling Manager
Global Drug Development
REG AFFAIRS GDD
East Hanover, NJ
Research & Development
The DRA Senior Global Labeling Manager (Sr. GLM) is responsible for the development and maintenance of regulatory compliant, competitive, and up-to-date core labeling documents for assigned key development projects and marketed products throughout the product lifecycle to ensure accordance with Novartis policies and procedures. The DRA Sr. GLM provides strategic and operational regulatory labeling input and works in close collaboration with Expert Labeling Task Force (ELTF) members, DRA sub-teams, and CPOs to ensure that the execution of global regulatory labeling plans are aligned with the global regulatory strategy and with Novartis labeling processes and standards.
Regulatory Labeling Strategy: Organize and lead cross functional expert labeling task forces (ELTFs) (including experts from DRA, Clinical, DS&E, DMPK, PCS, Reg CMC, etc.) to discuss labeling strategy, reach consensus on global labeling matters, assess impact of regional/local labeling changes on the CDS, and assist with the preparation of high quality documents to support the creation of the DCDS/CDS and/or changes to the core labeling for assigned projects or marketed products. Represent DRA GL as a core member of DRA Sub-teams, and Safety Management Teams (SMTs) and work in close collaboration with the GPRD and relevant line function expert(s) on creation/maintenance of core labeling documents. May update Global Program Teams (GPTs)/Global Brand Teams (GBTs) on an ad-hoc/issue-driven basis for assigned projects/products. Provide input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices. Contribute to DRA activities regarding Novartis safety risk communications/portfolio stewardship activities having labeling impact for their assigned projects/products. Contribute to overall Global Labeling and liability risk management strategy for Novartis Pharma including review of inter-divisional or cross-company pharmacovigilance agreements. Regulatory Labeling Activities: Global Product Information: Create and maintain regulatory compliant, competitive and up to date core labeling documents (Development Core Data Sheet/Core Data Sheet (DCDS/CDS), Basic Patient Leaflet (BPL), Basic Succinct Statement (BSS)) for assigned key development projects and marketed products. Ensure adequate reflection of key regional/CPO input (e.g. EU, US) when developing or revising the CDS. Review and release corresponding International Package Leaflets (IPL) CDS Supporting Documents: Organize/lead or contribute to the creation of high quality documents supporting changes to the CDS with internal and/or external experts including the preparation of responses to labeling-related Health Authority queries. Global Labeling Committee (GLC): Present and defend proposed DCDS/CDS and the changes in global product information documents, including labeling documents in key markets, to the GLC/(and MSRB for DCDS) for review and approval. Ensure that key country label proposals which deviate from a proposed CDS or CDS amendment/update (e.g., US PI, EU SmPC) are brought to the attention of the GLC, together with rationa
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Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred Fluency in English as business language, additional languages advantageous. Special expertise and seniority in the listed activities. Extensive experience (at least 4-6 years) in global labeling, alternatively extensive experience in related areas of the Pharmaceutical Industry or Health Authorities.
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