Neha Parashar
Sr. Executive - Regulatory Affairs
Medical
Biocon
India
Biography
Experienced Regulatory Affairs with a demonstrated history of working in the biotechnology industry. Total 4 Years of work experience in Corporate Regulatory Affairs, at Biocon Ltd. Bangalore and Mylan Laboratories Limited.
Research Interest
• Biosimilar product development • CMC Authoring (Module 2 and 3) • Lyophilized and Liquid sterilized products • Aseptic and terminal sterilized products • Change Control Regulatory Impact Assessment • Heath authority query resolution • Scientific guidelines (EU/US and ICH) • Life cycle management for biosimilars • Scientific advices (EU and US)