Regulatory Affairs Specialist
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I am an experienced Regulatory Specialist and Medical Writer with a demonstrated history of working in the pharmaceuticals industry. I am skilled in ICH E3 specifications, submission guidelines, publishing standards. Strong clinical research professional with a Post Graduate Diploma in Management focused in Marketing.
I have 9 years of experience in Regulatory Affairs management and Regulatory Submissions, with experience in filing NDA, INDs for US FDA, NDS and ANDS for Health Canada, and submission to EU, MHRA and Swissmedic. I also have experience in CMC module compilations, evaluation and advisement on the technical documents for submission of Module 3, and submission of Annual submission reports, PSURs, PBRERs and DSURs.
I have completed my PGDM from Welingkar Institute of Management, Mumbai, and completed my Masters in Biochemistry.
