Director, Regulatory Affairs (NY) (FullTime)

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Responsible for assisting VP, Reg. Affairs in coordinating and directing the strategy and conducting all meetings with FDA, and will regularly interact with the FDA and other regulatory agencies or organizations. Essential functions include working with senior management to develop product development strategies as well as providing regulatory guidance to the company’s product development team.

Qualifications

• The candidate will have at least 7 to 10 years relevant experience in biotech or pharmaceutical regulatory affairs, including experience with filing of INDs, NDAs, and BLAs.
• Degree in life science.