Global Regulatory Affairs Labeling Expert
2 days ago
Daiichi Sankyo, Inc. is seeking a highly skilled Global Regulatory Affairs Labeling Expert to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs).
Responsibilities
- Act as point of contact for cross-functional teams on global labeling issues.
- Manage updates to Core Data Sheets for assigned products.
- Manage US/EU and local country labeling deviations from CCDS.
- Prepare documents for review by labeling teams.
- Lead review processes and ensure appropriate governance for US, EU and Company Core documents as well as for the review of country labeling deviations.
- Research applicable Health Authority labeling regulations for products and filings.
- Manage compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both content and format.
Requirements
- 10 or more years of pharmaceutical industry experience required.
- 4 or more years of direct regulatory affairs experience, including CCDS and US/EU labeling experience required.
- Experience with country labeling a plus (outside the US/EU) preferred.
What We Offer
Daiichi Sankyo, Inc. offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, please submit your application.
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