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Senior Labeling Strategist

1 month ago

New York, New York, United States Della Infotech Full time
Job Description

As a Senior Labeling Strategist at Della Infotech, you will be responsible for creating, preparing, and revising CCDS, US, and EU labeling for mature and life cycle products. This includes coordination of labeling review and approval throughout the E2E labeling process, preparation of labeling components for submission to regulatory agencies, and participation in labeling negotiations with agencies resulting in product approvals or labeling updates.

Key responsibilities include:

  • Developing and implementing labeling strategies to ensure compliance with regulatory requirements
  • Collaborating with cross-functional teams to ensure labeling accuracy and consistency
  • Providing oversight and guidance on complex labeling projects
  • Anticipating and mitigating implementation hurdles
  • Staying up-to-date with regulatory requirements and industry developments

Requirements:

  • Bachelor's degree in a scientific discipline or relevant equivalent experience
  • Strong knowledge of regulatory requirements for CCDS, US, and EU labeling
  • Excellent communication, interpersonal, and organizational skills
  • Ability to lead regulatory strategy into labeling strategy
  • Strong analytical and project management skills

We are seeking a highly detail-oriented and organized individual with a strong analytical mindset and excellent communication skills. If you are a motivated and results-driven professional with a passion for regulatory affairs and labeling, we encourage you to apply for this exciting opportunity.