Sr. Manager, Labeling Regulatory Affairs
celgene - Berkeley Heights, NJ

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Prerequisites: Completed Bachelor’s degree in pharmacy or other scientific discipline with at least 4 years experience in the pharmaceutical industry required. Regulatory labeling experience or equivalent required. Completed advanced degree preferred. Position location can be either Berkeley Heights, NJ or Overland Park, KS.Summary Responsibilities will include, but are not limited to, the following: 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. Participate in development of labeling strategy, including contingency strategy for negotiation with FDA. Work with crossfunctional 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. Interface with Affiliate Regulatory Affairs personnel to obtain information and documentation. Update CCDS records and databases. Conduct labeling audits.

Assess impact of regulatory initiatives related to labeling; develop and implement systems to comply with these initiatives. Minimum Skills/Knowledge Required: Completed Bachelor’s degree in pharmacy or other scientific discipline with at least 4 years experience in the pharmaceutical industry required. Regulatory labeling experience or equivalent required. Thorough understanding of US labeling regulations and good understanding of the drug development process required.

Must have familiarity with global labeling regulations. Excellent communication (oral, written) and presentation skills are necessary for interaction with crossfunctional product labeling teams . Must have excellent editing skills, planning and organizational skills and strong interpersonal skills. Position location can either be Berkeley Heights, NJ or Overland Park, KS.Preferred Skills/Knowledge: Completed advanced degree preferred.

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About this company
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Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.