Regulatory Affairs Labeling Expert

4 days ago


Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time
Job Description

Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to creating innovative therapies for patients worldwide.

About the Role:

We are seeking an experienced Regulatory Affairs Labeling Expert to join our Global Regulatory Team as a key leader in product labeling and compliance.

About You:

The ideal candidate will have a strong background in regulatory affairs, with a minimum of 7 years of experience in the pharmaceutical industry and at least 4 years of direct RA experience, including US labeling expertise.

Key Responsibilities:

  1. Act as the primary point of contact for cross-functional teams on global labeling issues, ensuring alignment with Company Core Data Sheets and applicable regulations.
  2. Manage updates to Core Data Sheets for assigned products, ensuring implementation of CCDS/labeling agreements with licensing partners.
  3. Conduct Label Review Committee Meetings, preparing documents for review by labeling teams and ensuring appropriate governance for US, EU, and Company Core documents.
  4. Ensure compliance with labeling regulations and guidance, researching applicable Health Authority labeling regulations for products and filings.
  5. Establish processes and best practices, reinforcing labeling best practices at cross-functional meetings and assisting in the development of Standard Operating Procedures (SOPs).

What We Offer:

  • A competitive estimated salary range: $120,000 - $180,000 per year, based on location and experience.
  • A dynamic work environment with opportunities for growth and professional development.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.

Why Join Us:

Daiichi Sankyo, Inc. is an equal opportunity employer committed to diversity, equity, and inclusion. We strive to create a workplace culture that values and respects the perspectives and experiences of all employees.



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