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Senior Manager, Labeling, Regulatory Affairs

Req #: 1700917
Location: Summit, NJ US
Job Category: Regulatory Affairs
Work Location: 86 Morris Avenue CELSUM 07901
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Summit East

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

PREREQUISITES

Bachelor’s degree in pharmacy or other scientific discipline with 4-8 years experience in pharmaceutical industry.  Advanced degree preferred.  Regulatory labeling experience or equivalent required

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 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
    • 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

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

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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