Satish Nachaegari
Vice President, Global Regulatory Affairs @Esperion
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WORK HISTORY
Vice President, Global Regulatory Affairs @Esperion
Salt Lake City, UT, US
EDUCATION
Regulatory Affairs Professional Society
Regulatory Affairs Certified (U.S.)
Kakatiya University
B. Pharm, Pharmaceutical Sciences
National Institute of Health, Clinical Center
NIH Clinical Center Course, Principles of Clinical Pharmacology
National Institute of Pharmaceutical Education and Research
Master of Pharmacy, Pharmaceutical Technology
SKILLS
ABOUT SATISH NACHAEGARI
Providing expert regulatory affair leadership and strategies. Pharmaceutical scientist with 20+ year experience. Expert in regulatory affairs and passionate about new product development. Highly-effective in developing regulatory affairs strategies, including documentation and presentation. Self-driven professional with hands-on mentality and experience(s) in regulatory, clinical, non-clinical and formulation. Professional Skillset includes, but is not limited to: Regulatory submissions US drug regulatory; regulations 505(b)(2), IND, NDA, Orphan drug, PREA, Sub-part H FDA advisory committee meeting Canadian clinical trial application FDA eCTD authoring, review Non-clinical study Drug metabolism and food effects Receptor pharmacology Clinical study data, SDTM, ADaM, BIMO Statistical analysis plans, TLFs Clinical study design, protocol, study reports Clinical pharmacology and pharmacokinetics Pharmacokinetic data analysis and modeling IVIVC Oral formulation development and manufacturing (unique technologies) Lipidic and Lymphatic drug delivery
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