More than one and half years of technical regulatory experience in Small Molecules Marketed products for both new and matured products including oral dosage forms.
Good experience in building Regulatory strategy for both development and post marketed submissions for USFDA and other global health authorities
Good experience in Change control Management (review and assessment), Chemistry Manufacturing and control updates
Very Good understanding of regulatory requirements for post approval CMC changes for drugs and biologics and related guidance such as comparability protocols, BACPAC II and SUPAC
Comprehensive understanding of regulatory guidance for drug substance, drug product and their stability
Comprehensive knowledge of Quality by Design (QbD) and ICH guidelines such as ICH Q8, Q9, Q10 and Q11
Proficient with the guidance for product recalls, and field inspections
Experience in authoring and reviewing Module 3 (CMC) of CTD submissions (IND, IMPD, NDA, MAA and BLA), FDA correspondences (submissions, meeting requests, etc.) and responses to warning letters
Experience in creating Validation protocols, SOPs, Batch records, OOS forms and Deviation forms
Basic Familiarity with regulatory guidance for biologics and medical device submissions
Excellent communication, organization, interpersonal and project management skills
Proficient in using various systems like Rapid ( Documentum), Trackwise, Global Submit, Touchpoint and archival systems etc.,
Basic familiarity of Development of Biologics and regulations and guidances revolving around chemistry , manufacturing and controls
Pharma Technical Regulatory (Consultant) @ From December 2012 to Present (3 years 1 month) San Francisco Bay AreaRegulatory Affairs Specialist @ From November 2012 to Present (3 years 2 months) Advanced Notetaker @ From September 2010 to June 2011 (10 months) Graduate Research Assistant @ From March 2011 to May 2011 (3 months) Intern @ From May 2009 to April 2010 (1 year)
2012, Drug Regulatory Affairs @ Northeastern University, Boston, MA From 2010 to 2012 Bachelor of Pharmacy (B.Pharm.), Pharmaceutics @ Jawaharlal Nehru Technological University From 2006 to 2010 Bharathi Mamidipudi is skilled in: Regulatory Strategy Development, CMC Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, GMP, Pharmacovigilance, FDA, Sop, Change Control, SOP