Gokhale, Ph.D., RAC
Drugs & Biologics
Mamata is an enthusiastic Regulatory Affairs professional with extensive product development experience in the Pharmaceutical and Biotech industry (12 years) and Regulatory agency at the USFDA (5 years). Mamata also has wide clinical development experience with small molecules and biologics through all phases. As a leader, team player, reviewer and mentor, Mamata has shouldered increasing responsibilities in the industry and prior to that at the USFDA.
Having worked in a large global corporation (Amgen), a medium size company (Watson/Actavis) and a small start-up company (Neumedicines), Mamata can relate to the different needs and is able to set the direction and procure resources to meet the deliverables.
Mamata’s regulatory experience includes developing regulatory strategies, leading and managing regulatory interactions, IND and NDA/BLA filings, review and critique of briefing packages for various regulatory meetings, orphan drug and fast track applications and integrated safety and efficacy summaries, resolution of clinical hold issues, filings for, researching guidances and databases, developing SPA documents, building target product profiles, development of product core data sheets, labeling updates and managing e-submissions.
Mamata also has highly complementary and relevant clinical experience that includes developing study concept documents and protocols, interacting with Key Opinion Leaders and data safety monitoring committees, drafting and reviewing Protocols and Investigator Brochures, compiling and reviewing clinical study reports, project management, conducting study feasibility, evaluating budgets for clinical trials, pharmacovigilance and resolution of audit findings.
Mamata has worked in several therapeutic areas such as oncology, immunology, inflammation, cardiovascular, pulmonary, wound infections and radiation sickness.
Familiarity with all phases of drug development allows Mamata to align nonclinical and clinical development with regulatory strategies and functioning at regional and global levels in multicultural environment.
Mamata earned her Ph.D. from University of Bombay (accredited in USA), trained as postdoctoral fellow at Johns Hopkins University (JHU School of Medicine and School of public Health) and as a staff fellow at the FDA. Mamata has RAC certification from RAPS and Associate training in ISO 9001:2000 Quality Management System. Mamata maintains academic ties with University of Southern California by lecturing at International Center for Regulatory Science.