Senior Executive - Corporate Regulatory Affairs
Since March 2014
- Responsible for regulatory submission for Pharmaceutical products and management of product registrations and regulatory compliance. - Timely submission of dossiers of all categories of registration & maintaining regulatory database. - Arranging additional country specific requirements, response to queries. - Coordination with Different Departments (Research and Development, Quality Assurance, Quality Control and Marketing Department) for Technical Documents Required for Registration and Query response - Preparation of Strategic Planning for Compilation of Technical Documents for Regulatory Submission
Regulatory Affairs Executive - International Market
November 2011 --- February 2014
• Dossier preparation of Pharmaceutical Products. • Responsible for regulatory submission for Pharmaceutical products for Emerging Market (like Kenya, Botswana, Cameroon, Turkmenistan, Hongkong, Libya, Kuwait, Senegal, Yemen, Zambia, Ivory Coast, Paraguay etc.). • Development & Evaluation of Artwork for existing and new products • Maintain databases of the regulatory status and other pertinent details related to Products and Registration • Responsible for maintaining all regulatory documentation (licenses, certificates, etc) related to Manufacturing unit in compliance with country regulations. • Knowledge of various ICH guidelines, eCTD and cGMP guidelines. • Co – ordination with QA, QC and Production departments for getting samples and documents. • Review of technical documents.
Technical Executive - International Market
July 2010 --- November 2011
Work profile: • Working with the International Marketing and Technical Team. Co-ordinate with R & D scientist to solve the technical queries of customer • Co-ordinate with Regulatory and QA team for international regulatory affair • Job Involved is of further Business development as well as handling existing customers.
PGD in Pharmaceutical Management in Pharmaceutical Management from B. K. School of Management, Ahmedabad in 2012
M.S. (Pharm) in Natural Products from NIPER, Ahmedabad in 2010
B. Pharm in Pharmaceutical Science from Birla Institute of Technology in 2007