Senior Labeling Strategist

24 hours ago

Cork, Cork, Ireland beBeeLeadership Full time €90,000 - €120,000
Job Description

We are seeking an experienced senior leader to spearhead the development and maintenance of global labeling for our clients' affiliates. The successful candidate will provide strategic leadership for the development of a comprehensive global labeling strategy, implement key initiatives related to global labeling strategy, and serve as a global labeling representative for assigned products.

Key Responsibilities:
  • Develop and maintain core labeling documents related to drug, device, CMC, and carton/container components.
  • Ensure timely delivery of global labeling to facilitate simultaneous global submissions.
  • Lead timely updates and communication of core labeling changes throughout the product lifecycle.
Leadership and Collaboration:
  • Provide leadership and influence cross-functionally to drive regulatory excellence and innovation.
  • Partner with Global Regulatory Lead and Device Strategy Lead to support global labeling strategy.
  • Communicate effectively with global affiliates and stakeholders to ensure alignment with core labeling.
Requirements:
  • Bachelor's degree in a scientific or health sciences discipline (or equivalent experience).
  • Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 2 years.
  • Demonstrated knowledge of the drug development process and regulatory/business strategies.
  • Strong communication, teamwork, and organizational skills.

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