Akhila Parthasarthy

WORK HISTORY

EDUCATION

SKILLS

ABOUT AKHILA PARTHASARTHY

Comprehensive knowledge of development of small molecules, biopharmaceuticals, gene therapy and their regulatory requirements specifically for Chemistry, manufacturing and controls (CMC).• Good understanding of US FDA, ICH, Canadian and EU guidelines required for strategizing investigational and marketing applications pertaining to small molecules, biologics, gene therapies and medical devices. Proficient in preparing Health Agency meetings and interactions with different agencies.• Experienced in regulatory applications for gene therapy products at early stages and late stages (BLA/MAA).Proficient with preparation and review of Module 2 and 3 of regulatory submissions in CTD format. Extensive experience is redacting tier 1 dossiers to develop the International Core File (ICF) for submission in ROW (tier 2) countries. • Experienced with marketing applications in major markets (US, Canada, EU, Australia, Switzerland) and the rest of the world markets (LATAM, APAC, China, Japan, Israel). • Preparing efficient and streamlined regulatory strategies based on the requirement of each market to ensure quicker and faster approvals with fewer questions.• Experienced with post-marketing supplements and strategies for NDA and BLAs. Proficient in analyzing and assessing change controls.• Experience in preparing successful filings for combination products and well versed with device regulations and requirements for filing• Ph.D. in Biochemistry and an experienced Research Scientist in Oncology. Regulatory Affairs certification (RAC) from the Regulatory Affairs Professional Society (RAPS).• Excellent communication, interpersonal skills and strong leadership initiatives.Extensive knowledge of core sciences- Molecular biology and Biochemistry- Analytical methods- Oncology- Neuroscience- Immunology.