Senior Regulatory Affairs Lead — IND​/NDA Strategy

A leading biotechnology company is seeking an Associate Director, Regulatory Affairs in Framingham, Massachusetts. This role involves contributing to regulatory submissions and providing expertise across pre and post approval activities. The ideal candidate has a degree in Chemistry, Pharmacy, or Biological Science with over 10 years of experience in regulatory affairs, particularly with FDA and Health Canada submissions. Strong communication skills and project management experience are essential for collaborating cross-functionally to ensure compliance and successful product commercialization.
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