Director, Labeling

3 days ago

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Logo of Daiichi Sankyo US

Daiichi Sankyo US

Daiichi Sankyo β€’ Inc. is a member of the Daiichi Sankyo group of companies and is focused on the development of oncology therapies and specialty medicines. β€’ Oncology β€’ Specialty Medicine

10,000+

Description

β€’ Serve as Global Regulatory Affairs Labeling Strategy expert β€’ Manage development and maintenance of CCDS, US and EU labeling β€’ Review country labeling deviations for compliance with regulations and guidelines β€’ Mentor and manage labeling staff and cross-functional teams

Requirements

β€’ Bachelor's Degree preferably in a scientific discipline required β€’ Advanced degree (e.g., Masters, Pharm.D., Ph.D.) preferred β€’ 10 or More Years pharmaceutical industry experience required β€’ 4 or More Years of direct regulatory affairs experience, including CCDS and US/EU labeling experience required β€’ Experience with country labeling a plus (outside the US/EU) preferred

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