Luke A. Zack, PharmD Candidate 2017

Wilkes University, Nesbitt College of Pharmacy

Regulatory Affairs Intern, Noven Pharmaceuticals, Inc.

IPhO Senior Intern

A strong regulatory strategy is key to maximizing a product’s commercial success, optimizing the sponsor’s drug development efficiency, and enhancing credibility with regulatory agencies. So what tools are used to help build this vital strategy?

Developing a successful regulatory strategy requires the ability to research, review, create, propose, defend, and negotiate key regulatory positions to support product development, approval, and lifecycle management activities in global markets. An efficient regulatory strategy provides direction to support key planning, operational, and financial decisions critical to the sponsor. More importantly, an effective regulatory strategy can provide faster entry into the market while simultaneously providing evidence of meeting efficacy, safety, and benefit-risk standards.