Shivam Vashisth
Associate Director @Syneos Health
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WORK HISTORY
Associate Director @Syneos Health
EDUCATION
Government senior secondary school, Safidon, Jind
10+2, Medical science
Maharshi Dayanand University
Master's degree, Pharmaceutical Sciences
Hindu College of Pharmacy
Bachelor of Pharmacy (B.Pharm.), Pharmacy
SKILLS
ABOUT SHIVAM VASHISTH
Shivam Vashisth, M Pharmacy, Drug Regulatory Affairs (DRA), has over 13 years of experience in regulatory submissions (RA, Clinical & CMC) with strong project management skills in identification/mitigation of regulatory risks/issues to meet strict project submission/approval timelines. Subject matter expert (SME) in preparation and submission of Initial Clinical Trial Applications (EU-CTR & EU-CTD), Substantial/Non-Substantial Modifications (SM/NSM-Article 81.9), CTD to CTR Transition Applications, CTIS Notifications, Serious Breach, Urgent Safety Measures etc. Hands on experience in management of Part-I/II RFIs from various EU Member States (MSC). Regulatory professional with technical experience in authoring of CMC modules for US IND and EMA Marketing Authorization Application (MAA) submissions. Life cycle maintenance experience- License Renewals (RA/CMC experience), US FDA Annual Reports (AR), Labelling Updates, CMC Variations for global markets (EU, US) & Emerging markets HA Queries etc. In addition, Shivam has experience in Regulatory Strategy, Regulatory Intelligence, Scientific advice, CMC authoring (DMF/EDQM CEP), and regulatory inputs for business development etc.
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