Regulatory Affairs Labeling Expert
4 days ago
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:
- 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.
- Manage updates to Core Data Sheets for assigned products, ensuring implementation of CCDS/labeling agreements with licensing partners.
- Conduct Label Review Committee Meetings, preparing documents for review by labeling teams and ensuring appropriate governance for US, EU, and Company Core documents.
- Ensure compliance with labeling regulations and guidance, researching applicable Health Authority labeling regulations for products and filings.
- 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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