Naman Wadhwa
IT Risk and Audit Specialist-compliance Lead at Roche
Based in Toronto, Canada
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Seniority
Other
Department
Other
Location
Toronto
Industry
Biotechnology Research
Company size
107K
Contact information
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n•••••••@roche.com
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Background
About Naman Wadhwa
As a Regulatory Affairs graduate with a robust foundation in life sciences and extensive experience in translational biotechnology research, I excel in ensuring regulatory compliance and navigating complex regulatory landscapes. My Master's in Regulatory Affairs from Northeastern University has equipped me with comprehensive knowledge of regulatory submissions, compliance standards, and all stages of product development, from preclinical to post-market surveillance, including QA & QC. I have practical experience in medical device regulations, having developed a regulatory strategy for an AI-based smart inhaler. My diverse skill set includes pharmacovigilance, eCTD, FMEA, quality control, CMC, CAPA, data extraction, and Python for clinical trials and product development. I am eager to leverage my expertise in regulatory affairs to drive scientific innovation and regulatory success in a new role. My dedication to compliance and passion for life sciences make me a valuable asset to any organization aiming to achieve regulatory milestones and advance industry advancements.
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