Pardha S.

Master's in Regulatory Affairs|| Actively seeking Full time opportunities | Regulatory Affairs-CMC | MS Regulatory Affairs Drugs Biologics & Medical Devices | Biopharmaceuticals | Quality Assurance at Balaxi Pharmaceuticals Limited

Based in Boston, United States

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Seniority

Other

Department

Other

Location

Boston

Industry

Pharmaceutical Manufacturing

Company size

170

Contact information

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Email

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p•••••••@balaxipharma.in

Phone

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Background

About Pardha S.

>>I am a results-oriented Regulatory Affairs professional with a Master’s in Regulatory Affairs for Drugs Biologics and Medical Devices from Northeastern University. With a background as a licensed Pharmacist I bring strong knowledge of drug safety regulatory compliance and therapeutic applications. >>My expertise includes preparing regulatory submissions (IND NDA ANDA CTA) eCTD dossier compilation labeling compliance and regulatory intelligence aligned with FDA EMA and Health Canada requirements. >>Skilled in Microsoft Excel Microsoft Office and lab equipment handling I combine technical accuracy with attention to detail. I thrive in fast-paced high-regulation environments and enjoy solving challenges with a proactive team-oriented mindset. >>A quick learner with a passion for regulatory science I am committed to ensuring product quality safety and timely market access through strong regulatory strategy and execution.

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