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Bengaluru Area, India India

Drug Regulatory Associate at Kinapse India PVT Ltd

Medical / Health Care / Pharmaceuticals

• 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...