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Mumbai Area, India India

Manager - Regulatory Affairs, SIDMAK Laboratoris Pvt. Ltd.

Medical / Health Care / Pharmaceuticals

Profile Snapshot: A high-end Regulatory professional having 12+ years of experience in pharmaceutical industry presently associated with Sidmak Laboratories (I) Pvt. Ltd as Manager - Regulatory Affairs. Competent with effective leadership that leads to high quality regulatory strategies, documentation and presentations meets standard timeline and achieve approval on the submissions. Dosage Forms Handling: Solid Orals (Conventional, Modified and Controlled), Transdermal Products. Submission Type Handling: ANDA, PAS, CBE, Deficiencies. eCTD Software handling: PharmaReady by Navitas (formerly Take Solution). Key Skills: Regulatory Affairs, formulations, ANDA, US FDA, Strategic Planning, cha...