John Kirk, ScD, MS, is a principal regulatory strategist at Veristat with over 40 years of experience in regulatory affairs, supporting global clients from early development through marketing authorization and post-approval. He specializes in rare diseases and helps align regulatory strategies with agency expectations and patient needs. Kirk has held senior roles at Amicus Therapeutics, Millendo Therapeutics and Aegerion Pharmaceuticals, leading global regulatory activities including NDA, MAA, and post-marketing submissions. He has also provided regulatory consulting for emerging biotechs. Kirk holds a BS in biological sciences, an MS in chemistry, and an ScD in outcomes research from Tulane University. He can be reached at john.kirk@veristat.com.
John Kirk
Opinion author
