Sumit Gupta

Formulation Regulatory Affairs-Europe Market

Role: Regulatory Affairs-europe Market at Unichem Laboratories Limited
Location: Mumbai, MH, IN
LinkedIn followers: 500 followers

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Experience

Regulatory Affairs-europe Market
Unichem Laboratories Limited
Nov 2024 — Present · Mumbai, IN
Preparation, compilation, submission of the Pre-filling activities, Dossier- CMC for Europe market in eCTD format using Pharmaready and Educe software.Responses for Queries/Deficiencies received from Client/Authorities.Preparing and submitting variation packages (Type IAIN, IA, IB, II) post approval activities that enhances the outputs and product quality.

Education

Bharati Vidyapeeth
Diploma, Pharmacy
Poona College of Pharmacy, Pune
Bachelors of Pharmacy, Master of Pharamacy
2015 — 2018
Vivekanand Education Society's College of Pharmacy
Master of Pharmacy, Quality Assurance
2018 — 2020

Contact information

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•••••@unichemlabs.com
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Current company

Unichem Laboratories Limited

Pharmaceutical Manufacturing · 4.3K employees · Mumbai, Maharastra, India

Promoted by the late Mr. Amrut Mody, a pioneer of the Indian pharmaceuticals business, Unichem Laboratories has grown to become one of India's most respected pharmaceutical companies. It is committed to deliver better health through superior products. By combining strategic research and in-depth industry knowledge, Unichem aims to transform itself into a global pharmaceutical drug Company with an increasing focus on cutting-edge research and developed markets. With formulations constituting the core of the company’s business, Unichem is backward integrated to API Manufacturing, which adds value to the customer in terms of quality and sustainability. Inspired by an ambition to drive path-breaking innovative research, Unichem aims to enhance people’s health by consistently providing better, more effective and safer products.

unichemlabs.com

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Experience

Regulatory Affairs-europe Market

Education

Bharati Vidyapeeth

Poona College of Pharmacy, Pune

Vivekanand Education Society's College of Pharmacy

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