Senior Labeling Strategist

1 day ago

Dublin, Dublin City, Ireland beBeeLabeling Full time $148,300 - $241,900
Senior Labeling Manager

This role offers the opportunity to lead and develop regulatory labeling strategies, ensuring compliance with FDA, EMA, and international regulations. As a Senior Labeling Manager, you will be responsible for managing the development, review, approval, and maintenance of Company Core Data Sheets (CCDS), USPI, EU Sm PC, and Rest of World (Ro W) labeling.

Key Responsibilities:

  • Manage the regulatory labeling process throughout the product lifecycle.
  • Lead the development of labeling strategies through interpretation of labeling regulations, guidelines, and competitor analyses.
  • Develop target labeling documents to support design and analysis plans for clinical trials.
  • Provide labeling expertise on complex issues to stakeholders.
  • Anticipate Health Authority perspectives and broader implications of strategies, proposing alternatives and providing advice to mitigate risk.

Required Skills and Qualifications:

  • Bachelor's degree in Life Sciences or related field.
  • Advanced degree (Masters, Pharm D, Ph.D., MD, or DO) preferred in the field of medicine or science.
  • Regulatory experience can offset education requirements.
  • 3-4 years of related Biotech or Pharma industry experience, 2 or more of which are working with labeling.
  • In-depth knowledge of the labeling process, industry practice, packaging manufacturing process, and the drug development process.
  • Familiar with policies and operating procedures in medical safety regulatory and/or corporate and worldwide Regulatory Agencies.

Benefits:

  • An inclusive and diverse culture that provides comprehensive benefits.
  • A competitive salary range of $148,300.00 - $241,900.00.

About Regeneron:

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic.

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