Drx Manoj Singh Khanayat
Regulatory Affairs Sr Executive @Hanuchem Laboratories - India
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WORK HISTORY
Regulatory Affairs Sr Executive @Hanuchem Laboratories - India
IN
Motivated Regulatory Affairs professional currently working at Hanuchem Laboratory in the Regulatory Affairs department, supporting international registrations and compliance for pharmaceutical products.Experienced in preparing and reviewing CTD/ACTD dossiers, product permission files, and regulatory documentation for various markets while ensuring alignment with current cGMP, ICH, and country-specific guidelines.Skilled in coordinating with cross‑functional teams, responding to regulatory queries, and maintaining organized regulatory records to support smooth product approvals and lifecycle management.Eager to continue learning, contribute to high‑quality submissions, and grow in global drug regulatory affairs roles
EDUCATION
Amrapali University Haldwani
Bachelor of Pharmacy - BPharm, Pharmacy
Uttarakhand Technical University
Master in pharmacy , Regulatory
Dev Bhoomi Uttarakhand University
D pharma
ABOUT DRX MANOJ SINGH KHANAYAT
A dedicated and detail-oriented Regulatory Affairs professional with over two years of experience in the pharmaceutical industry, specializing in market entry and regulatory compliance across diverse regions including African countries, CIS countries, and Latin America. Demonstrated expertise in preparing and submitting regulatory documents such as Common Technical Dossier (CTD), ACTD,ensuring compliance with regional regulations, and managing the lifecycle of drug products from initial approval to market launch.Experienced in the preparation and review of critical technical documents including Summary of Product Characteristics.(SMPC).PIL.Insert.MSDS.ArtworkKnowledgeable in artwork creation and review to ensure regulatory compliance and brand consistency. Demonstrated ability to navigate complex regulatory environments, collaborating with cross-functional teams to ensure timely and successful product registrations and market launches.
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