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Mumbai, Maharashtra, India India

Scientist

Medical / Health Care / Pharmaceuticals

Experienced professional in the field of Regulatory Affairs, Analytical Development and Quality Control Having experience of ANDA/dossier compilation and submission along with deficiencies handling for Solid oral dosage forms in eCTD/CTD format (US, Japan Regulated and Semi/Other Rest of the World Market) Compilation, review and submission of Pre and Post-approval supplement for Solid Oral dosage forms along with maintenance of the documents submitted to regulatory body Review change control in order to assign appropriate regulatory determination to post approval changes Assessment of prototype document & technical documentation package for compilation of dossier and supplements Co-...