Personal Information
Organization / Workplace
Bengaluru Area, India India
Occupation
Drug Regulatory Associate at Kinapse India PVT Ltd
Industry
Medical / Health Care / Pharmaceuticals
About
• Regulatory affairs professional with 1.5 years of experience in registration of dossiers to Asia pacific and Gulf countries.
• Having experience in compilation & submission of renewal dossiers to Asia Pacific and Gulf countries according to the format & guidelines issued by the respective drug regulatory authorities.
• Compilation of renewal dossiers in ACTD and eCTD format.
• Authoring the high quality CMC dossier sections as per country regulatory authority format.
• Applying and tracking the CoPP, GMP and ML documents for renewal submissions.
• Co-ordinate with various cross functional teams for documents, coll...
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