Naveen Kumar Nagaraja
Assistant Director Regulatory Affairs
Takeda
C-4, MIDC, TTC Industrial Area, Village Pawne, Thane Belapur Road, Navi Mumbai – 400 705, India
http://www.zydustakeda.com/
A comprehensive experience of 14 years in Pharmaceutical Industry with regulatory affairs as a strong domain in addition to pharmacovigilance, quality and sales. Passion and aggression gained during sales tenure compliments technical facets of regulatory affairs making it easy to understand science behind every new product and present it with conviction to the regulators.
Skill: Drug Regulations, Product Registrations, Clinical Trials, Pharmacovigilance, Supply Chain, Quality, Product Launch, and Matrix Management
In the current role responsible for regulatory and quality functions in India.
o System and process establishment for regulatory operations
o Secure approval for product launches and CT execution
o Develop regulatory strategy for local business and exports out of India
o Identify the product flow for imports per local regulations
o Department budget preparation and control
