Loren Gelber - DELEGATE, Ph.D.
I am an independent pharmaceutical consultant specializing in Regulatory Affairs and GMP Compliance. I have 10 years of FDA experience, 30 years in the pharmaceutical industry and 13 years as a consultant.Lately I have been giving webinars and seminars about the FDA regulations for OTC drugs. I write INDs, 505(b)(2) NDAs, ANDAs and some 510k's.
I chose this career path because
I started in Bio Chemistry in 1965, received my Masters in Organic Chemistry, and traveled with my husband in the Air Force. When I came back to the United States I applied for Civil Service to get into the FDA and worked in the lab as a HPOC expert. I went on to work as a Pharma Chemist in Regulatory Affairs, and I now currently work as a consultant for small companies.
I prepared for this career by
I received my Master's in Chemistry from Brooklyn Polytechnic Institute and went on to receive my Ph.D. in Medicinal Chemistry from Northeastern University.
The biggest challenge I've overcome
The biggest challenge is being the only woman in the room.
My greatest strength(s)
Among my greatest strengths are my abilities to see the big picture, asking the right questions, and explaining the FDA to clients.
My greatest accomplishment to date
My greatest accomplishment is helping medium size pharmaceutical companies find the products that are right for them for them with the expectation of getting FDA approval. I specialize in regulatory affairs and compliance.
My personal/professional goals
My professional goal is to continue consulting for small companies.
I most want to be known/remembered for
I want to be remembered for my contribution to compliance, the GMP, and how applications are submitted.
I participate in the following organizations/memberships
I am a member of Phi Beta Kappa and The American Chemical Society.
I enjoy the following hobbies/interests
I enjoy reading and doing needle point for my grandchildren.