Regulatory Labeling Strategy Manager

Our client is a global biopharmaceutical company with multiple approved products available in over 100 countries.  They are seeking a Regulatory Labeling Strategy Manager to support successful development of Company Core Data Sheets (CCDSs) and global labeling.  You will implement regulatory labeling strategies for new and revised prescribing information and packaging.  In addition, you will liaise with regulatory team members and provide labeling input regarding evolving submission and negotiation plans.

Responsibilities:

  • Implement regulatory strategy for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products.
  • Manage and facilitate development and review of the CCDS and US and EU labeling in conjunction with the Labeling Teams.
  • Facilitate consensus among Labeling Teams on labeling decisions.
  • Document labeling changes in appropriate decision records.
  • Assists in the review and response of Health Authority queries relating to labeling.
  • Manage labeling logistics including version control of product labeling and other related documentation.
  • Ensure all labeling supporting information is sent for archiving in electronic document management systems.
  • Implement all labeling process improvement initiatives.
  • Interpret scientific and clinical data and leads development of labeling to optimize product potential and patient benefit – risk ratio.
  • Maintain awareness of regulatory legislation pertaining to labeling, assessing and communicating impact as appropriate.
  • Prepare final proposed labeling, as needed, for review and endorsement by the Labeling Team and Executive Labeling Committee prior to Health Authority submission.
  • Communicate new and revised CCDS to all relevant internal and external parties.

 

Education and Experience Requirements:

  • Bachelor’s degree in a scientific discipline or closely related field is preferred.
  • Five or more years of regulatory or related experience in the pharmaceutical/ biotechnology industry with at least 2-4 years of direct Labeling experience.
  • Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling.
  • Expertise in developing company core data sheets (CCDS)
  • Knowledge of global guidances relevant to labeling, drug development, and commercialization of prescription medicines.
  • Understanding of EU and US labeling requirements and guidance for legacy and PLR labels and ability to communicate and resolve issues during labeling reviews and conversations.
  • Understanding of XML and Electronic Document Management Systems to a sufficient level to support labeling documentation.

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