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Smriti P

Clinical Regulatory Affairs

Occupation:

Clinical Regulatory Affairs

Education Level:

Master

Will Relocate:

YES

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Professional Summary Regulatory affairs associate adept in research and documentation of product dossier. Provide clear and concise information based on creative and complex findings. Also a dedicated lecturer with a stong work ethic. Skillfully manages lectures and promotes open classroom discussions. Regulatory affairs associate Jan 2011 - Feb 2012 Alice Pharma Pvt Ltd Mumbai, India * Regulatory Dossiers Preparation. * Co-ordinate with cross functional department for primary data documents, certificates & samples required for submission collate and review primary data received from different departments towards regulatory requirements. * Procuring the relevant clinical & non clinical data from Internet and books. * Handling queries and Compliance of notice of deficiencies raised by regulatory authority Providing literature and data to the designing personal for preparation of posters and promotional ad. * Coordinate with the client and marketing team for their feedback on product quality like packaging, promotional ads & new product launch. Lecturer Jan 2007 - June 2007 Oriental college of pharmacy Mumbai, India * Taught introductory and upper level courses in pharmaceutical sciences and pharmaceutics. * Developed and delivered engaging lectures to undergraduate and graduate students. * Wrote course materials such as syllabi, homework assignments and handouts. * Wrote, administered and graded midterm and final examinations. * Planned, evaluated and revised course content and course materials. * Supervised and evaluated students laboratory work. * Guided students in using technology to support educational research. * Coached students on public speaking and presentation skills. Sales executive Aug 2005 - Mar 2006

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