Regulatory Labeling Strategy

3 weeks ago

Cambridge, United States Randstad Life Sciences US Full time

Regulatory Labeling Strategy

100 % Remote - must work EST hours

Max PR: $165 an hour

  • Provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders for successful development of Company Core Data Sheets (CCDSs) and global labeling, i.e., US and EU (CP, MRP, and DCP).
  • Ensures that there is Labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans.
  • Formulates regulatory labeling strategies for implementation of new and revised prescribing information and packaging.
  • Provides expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance.

Job Responsibilities

  • Manages and facilitates development and review of the CCDS and US and EU labeling via the Labeling Teams.
  • Facilitates consensus among Labeling Teams labeling decisions.
  • Documents labeling changes in appropriate documentation.
  • Manages labeling logistics including version control of product labeling and other related documentation.
  • Ensures all labeling supporting information is sent for archiving in electronic document management systems.
  • Implements labeling process improvement initiatives.
  • Assists in the review and response of HA queries relating to labeling.
  • Proactively raises issues to management for dispute resolutions.
  • Implements regulatory strategy for cross-functional labeling teams for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products.
  • Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit - risk ratio.
  • Maintains awareness of regulatory legislation pertaining to labeling, assessing and communicating impact on business and products (liaising with Regulatory Intelligence colleagues as appropriate).
  • Facilitates cross functional Labeling Teams for successful development, and implementation of labeling strategies.
  • Prepares final proposed labeling, as needed, for review and endorsement by the Labeling Team and Executive Labeling Committee prior to Health Authority (HA) submission Communicates new and revised company core data sheets to all relevant internal and external parties

Education & Qualifications

  • Bachelor's degree.
  • 5 -8 years of regulatory or related experience in the pharmaceutical/ biotechnology industry.
  • 2-4 years of direct experience desired
  • Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling.
  • Expertise in developing company core data sheet.
  • Knowledge of global guidance 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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