Sathya Ganesan
Regulatory Strategist | Pharma Researcher
- Role
- Us Regulatory Science Lead at UCB
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Sathya Ganesan
With patients first mindset, I lead and drive regulatory strategy for products in all phases of clinical development, approval and post approval. Scientific research experience as a discovery and assay development scientist, enables me to communicate effectively with both internal/external stakeholders with mission and vision to make safe and effective therapies available to those that need them. My current interests are neurology/neurodgeneration (Epilepsy, Alzheimer\'s disease, Parkinson\'s and Progressive Supranuclear Palsy) and rare oncologies. As part of my volunteer activity, I led the Mentors, Advisors and Peers (MAPs) programs at Women in Bio. I recently completed a three year term with North Carolina Regulatory Affairs Forum (NCRAF) in a leadership role (Past President 2021) and engage in speaking opportunities at local universities for alternate careers for lifseciences PhDs. Career Highlights:~10 years experience in Regulatory affairs with increasing responsibilities in regulatory strategy, health authority interaction, meeting packages, pediatric development plans, orphan designations, IND/CTAs, marketing authorization submissions and post approval pediatric and efficacy supplements. Therapeutic areas: Oncology, immunology, neurology, musculoskeletal diseases 15 years of experience in drug discovery (endocrinology and women’s health, oncology of breast and prostate) and medical device development (implantable devices for orthopedics, soft-tissue repair and cell therapy). Preclinical lead scientist on numerous research projects that led to successful funding of 4 Phase II SBIR (Small Business Innovation Research grants) and several phase I grants totaling greater than $10 million and filing of two patents. Certification from Regulatory Affairs Professional Society (RAPS) in US FDA regulations.
Experience
Us Regulatory Science Lead
May 2020 — Present
Education
North Carolina Regulatory Affairs Forum
8-week workshop, Regulation of Medicinal Products in the EU
2014
Birla Institute of Technology and Science, Pilani
B.E(Hons), Electrical and Electronics Engineering
1989 — 1994
Johns Hopkins Bloomberg School of Public Health
Coursera - Design and Interpretation of Clinical Trials, Clinical research
2014
Birla Institute of Technology and Science, Pilani
MS, Biological Sciences
1989 — 1994
Duke University
Regulatory Affairs
2011 — 2011
Duke University
Post-doctoral fellow, Pharmaclogy and Cancer Biology
1999 — 2004
University of Rochester School of Medicine and Dentistry
PhD, Biochemistry
1994 — 1999
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