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Global Labeling Manager

Newark Metro Area, NJ

Posted: 02/21/2019 Job Type: Scientific Job Number: JN -022019-23748
Position: Regulatory Affairs Specialist re: regulatory labeling

Partner with Global Regulatory Strategy Leads and CCDS Teams in the development and maintenance of Company Core Data Sheets for assigned products.
Partner with Global Drug Safety in the development and maintenance of Development Core Safety Information (DCSI) for assigned products.
Partner with Regional Regulatory Strategy Leads in the development and maintenance of US prescribing information.
o Participate in development of labeling strategy, including contingency strategy for negotiation with FDA.
Work with cross-functional teams to ensure that desired label statements will be adequately supported by submission documents
Provide global and US regulatory labeling expertise to teams
Ensure that draft labeling complies with all applicable regulations and guidelines
Ensure compliance of labeling with Company Core Data Sheet; manage deviations
Research regulatory precedent for the labeling of related products
Train Regulatory Affairs staff and other functions on labeling regulations, guidances, and processes.
Work in close cooperation and coordination with EU Labeling Senior Manager for optimal efficiency
Assist Senior Director with management of CCDS process for assigned products, including management of deviations
Assist Senior Director with management of DCSI process for assigned products
Track implementation of revisions to CCDS into country labeling
o Interface with Affiliate Regulatory Affairs personnel to obtain information and documentation
o Update CCDS records and databases
o Conduct labeling audits
Assess impact of regulatory initiatives related to labeling; develop and implement systems to comply with these initiatives

Skills/Knowledge Required:

Bachelor s degree in pharmacy or other scientific discipline. Advanced degree preferred.
Regulatory labeling experience or equivalent required
4-8 years pharmaceutical industry experience
Thorough understanding of US labeling regulations; good understanding of the drug development process
Familiarity with global labeling regulations
Excellent communication (oral, written) and presentation skills necessary for interaction with cross-functional product labeling teams
Excellent editing skills
Detail oriented
Excellent planning and organizational skills
Strong interpersonal skills
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