Shade A.

Background

About Shade A.

I have a strong understanding of FDA regulations, policies, procedures and ICH guidelines. I have more than six years proven success in managing multiple projects while working under pressure in fast-paced environments. Earned a Master’s of Science degree in Bioscience Regulatory Affairs from Johns Hopkins University. My background is in regulatory affairs, including regulatory requirements for drugs, biologics, medical devices and clinical development. I am an expert at product development including intellectual property and licensing, regulatory strategies in biopharmaceuticals and GMP. I have practical experience in reviewing and preparing regulatory submissions including Pre-IND, IND, IDE, ANDA, BLA, CTD and in the life cycle management of these submissions. I have successfully prepared meeting requests, briefing packages for Pre-IND meetings, and an IND submission (CTD format) for a novel drug. I reviewed NDA submission documentation for consistency and compliance with applicable regulations and guidelines. Collaboratively worked with cross-functional teams to prepare the clinical development plan of a novel drug in the preclinical stage; designed nonclinical, clinical trials, and developed a risk mitigation strategy. My other regulatory writing experience includes preparing Requests for Designation (RFDs) for combination products; evaluating and advising on drug labels for usefulness from a sales and marketing perspective and constructing Target Product Profile for drugs to compete with the market standards.