Aimee Weber

Associate Director, CMC Regulatory

Aimee Weber

Associate Director, CMC Regulatory

Aimee Weber has more than 20 years of experience in the pharmaceutical industry, specializing in Chemistry, Manufacturing and Controls (CMC) for both drug product and drug substance development. As Associate Director of CMC Regulatory, Ms. Weber is responsible for working directly with clients, providing technical and strategic advice for CMC regulatory topics and authoring and reviewing sections of Module 3. She has supported clients from the Pre-IND through marketing application stages of development for pharmaceuticals and biologics in the US and internationally. Ms. Weber is well versed in eCTD format and has authored a variety of CMC submissions, including INDs, IMPDs, FDA meeting documents and has been involved with several marketing applications.

In previous roles, Ms. Weber has led a group of scientists responsible for analytical method development and validation, managed technical transfer activities to CDMOs, and led laboratory investigations. She has contributed to the development of a diverse range of drug substances covering multiple therapeutic areas and drug product formulation types, with extensive experience with semi-solid dermatological products. She earned her Bachelor of Science in Chemistry from Hope College in 1999 and her RAC certification in 2020.

Why Regulatory?

“I have worked in the pharmaceutical industry for a number of years and working in regulatory is a great opportunity to see the whole drug development picture. In regulatory, I have gained a much higher appreciation for the challenges that each area of development faces and have observed how project teams are able to work strategically and collaboratively to reduce these challenges.”


Content by Aimee Weber