Regulatory Affairs Assoc II

IVAX Pharmaceuticals, one of the nation?s leading manufacturer, seller and distributor of premier brand equivalent (generic) pharmaceutical products with over 1500 employees in 7 locations has the following opportunity open in their Congers, New York Office:

Regulatory Affairs Labeling Associate II
Responsibilities: Reporting to the Associate Director of Regulatory Affairs, this position is responsible for:
Product labeling for all marketed products
Create, proofread, edit and internally approve all labeling components
Respond to FDA comment letters
Maintain product database of labeling changes used by all levels of employees and management
Convert inserts to SPL (Structured Product Labeling)
Renew site registrations for all company sites, domestic and abroad
Interact with various print vendors and private label customers to redesign artwork and implement required revisions
Order and supply GMP documents,CPP's. legal documents and samples for registrations
Track innovator labeling changes and update labeling accordingly

Maintain global product database of global products, pending and approved by foreign health ministries
Requirements: BS in a scientific discipline and a minimum of 3 years experience in Regulatory Labeling is required, as is in-depth knowledge of FDA regulations and policies. Strong writing skills are a must.
An Equal Opportunity Employer and Drug Free Workplace



An Equal Opportunity Employer and a Drug-Free Workplace

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