regulatory professional with an experience in regulatory submissions for usa, europe, australia, new zealand and south africa markets. global project titled development and deployment of global Change Control process in Quality Management System trackwise® . post graduate in Pharmacy with specialization in Pharmaceutics. pursuing mba in Project Management.
Sr. Research Associate
Since August 2014
review & compilation of dossier for filing in usa market. compilation of various regulatory submissions, post approvals, site transfer, cost saving projects. efficiently expertise in reviewing, assessing, managing the documents needed for regulatory submission. compilation of annual reports of approved product in usa. ensure that all work is in Compliance with all pertinent SOP, glps and safe work practices. Review & compilation of dossier for filing in USA market. Compilation of various regulatory submissions, Post Approvals, Site transfer, Cost saving projects. Efficiently expertise in reviewing, assessing, managing the documents needed for regulatory submission. Compilation of Annual Reports of approved product in USA. Ensure that all work is in compliance with all pertinent SOP, GLPs and Safe Work Practices.
Regulatory affairsAugust 2013 --- August 2014
compilation and submission of high quality dossier (eCTD) to regulatory agencies (emea- eu, tga-australia, mcc- south africa, medsafe- new zealand). submission of emea Applications through documentum and citrix timely submission of response to queries raised by Health authorities assessments of the changes in registered products and filing of variations to respective markets correspondence and follow up with various departments of plant and R&D for Procurement and compilation of documents advice to various department as per the regulatory prospective during Product Development stage preparation of approval packages and sharing with Manufacturing locations processing global Change Control (gcc) records in trackwise®.
Global Change Control Officer, Global Regulatory ConformanceJuly 2012 --- July 2013
processing of Change Control records in Quality Management System trackwise. review and provide approval to the regulatory actions. provide subject matter expertise regarding the global Change Control program as related to Regulatory Affairs activities. this may include Troubleshooting assistance for process and/or system related queries. lead the monthly regional Regulatory Affairs global Change Control superuser teleconference. provide operational support to the gra management team including the preparation of monthly metrics reports and other procedural documents, Presentations, and coordinating meetings related to global Change Control and/or regulatory conformance activities. act as the key regional Regulatory Affairs subject matter Expert for deployment activities which support the roll-out of system & process enhancements. providing Training to new users of gcc system. providing recommendations for global Change Control enhancements and continuous improvement activities. reporting of monthly key performance indices. monitoring regulatory Databases and repositories to ensure Compliance.
Trainee- Global Change Control,Global Regulatroy ConformanceJuly 2011 --- July 2012
Skills and Expertise
Manage regulatory activitiesInteract with regulatory stakeholdersWriting regulatory documentsRegulatory submissions
Master of Business Administration (MBA) in Project Management from Sikkim Manipal University of Health, Medical and Technological Sciences in 2015
Certificate in General Course on Intellectual Property from World Intellectual Property Organization (WIPO), Switzerland in 2012
IPPRA in Pharma Regulatroy Affairs from Bioinformatics Institute of India, Noida in 2010
M.Pharm in Pharmaceutics from Guru Ghasidas University in 2010
B.Pharm in Pharmacy from Sagar Institute of Pharmaceutical Sciences, Sagar (M.P) in 2008