Nick Diel Email & Phone Number

I am a competent, trusted leader with 10+ years experience in regulatory, technical and R&D leadership. My experience covers a wide scope of drug development from Phase 1 clinical trials through approval and commercialization. I am currently the Project Director at St. Renatus, a pharmaceutical development company and developer of Kovanaze (tetracaine HCl and oxymetazoline HCl) Nasal Spray. As the Project Director, I was responsible for the submission and approval of the company’s first NDA.I’ve worn many hats in my career and worked in areas ranging from regulatory strategy, clinical development, product development, manufacturing, and IT. This has allowed me to lead multi-disciplinary projects and solve complex problems. I am passionate about my work and I get excited taking on new challenges. I believe in the importance of a well functioning team. While I strive to excel as a visionary, I believe execution matters most. When I am not working, I love playing tennis, traveling, and enjoying good food. I enjoy reconnecting with old colleagues and connecting with new ones, so don’t hesitate to reach out and connect.Competencies: Regulatory strategy; product development; clinical study design; adverse event analysis; GCP, GMP, & GLP; data management and analysis; conducting meetings with the FDA; CRO management; pharmaceutical drug manufacturing; design controls; IT management; team building and collaboration.

Listed skills include Project Management, Regulatory Affairs, Product Development, Regulatory Strategy Development, and 8 others.

• 

  Colorado State University

  Computer Engineering