Regulatory Affairs Expert

5 days ago


San Francisco, California, United States Daiichi Sankyo, Inc. Full time
Key Responsibilities:

As a Regulatory Affairs Expert at Daiichi Sankyo, you will play a critical role in ensuring the compliance of our products with global regulations and guidelines. This includes managing the development and maintenance of Company Core Data Sheets (CCDS) for assigned products, as well as driving the maintenance of global labeling and associated documents. Additionally, you will lead cross-functional teams through labeling discussions with Health Authorities (HAs) while ensuring management alignment.

Key Qualifications:

We are seeking a highly experienced Regulatory Affairs professional with a strong background in labeling and regulatory affairs. The ideal candidate will have a minimum of 10 years of experience in the pharmaceutical industry, with 4 or more years of direct regulatory affairs experience, including CCDS and US/EU labeling experience. A bachelor's degree in a scientific discipline is required, and an advanced degree is preferred.

Why Daiichi Sankyo:

Daiichi Sankyo is a global pharmaceutical company dedicated to creating innovative therapies to improve standards of care and address unmet medical needs. With over 100 years of scientific expertise and a presence in over 20 countries, we offer a unique opportunity to work with a talented team of professionals who share your passion for innovation and excellence. As a Regulatory Affairs Expert at Daiichi Sankyo, you will be part of a dynamic team that is committed to delivering high-quality products to patients worldwide.

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