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Mini Vijay Kumar is listed as Pharmaceutical Corporate Quality and Regulatory professional at Consultancy services, based in Mumbai, Maharashtra, India. AeroLeads shows a matched LinkedIn profile for Mini Vijay Kumar.
Mini Vijay Kumar previously worked as Director (Quality and Regulatory Consultant and trainer) at Consultancy Services and Head - Corporate Quality for 6 Systems Compliance at Plant and R&D and Regulatory Affairs at Sidmak Laboratories (I) Pvt. Ltd.. Mini Vijay Kumar holds Chemistry from Graduation In Chemistry From K J Somaiya, Mumbai And Mba From Itm Under Articulation With New Hampshire, Usa..
PHARMA professional with experience spanning almost three decades having in-depth knowledge in International cGMP and US FDA CFR requirements. Worked as Head Quality, Regulatory and Compliance operations on 6 systems in plant and R&D. Spearheaded consecutive US FDA audits with approval. Prepare ANDA and CTD dossier submissions in USA and Europe and other Regulated and non- Regulated markets.
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Mumbai, Maharashtra, India
Worked for Global Quality and Regulatory consultations, training on cGMP, six system Compliance, Global Regulatory filing strategies, CFR training, GAP Analysis for API plants and Formulation plants, Deficiency response, Dossier submissions and DMF submissions in CTD format.
Mumbai And Dehradun
PRESIDENT- Quality for Six Systems at Plant and R&D.Most Responsible person at Sidmak for US FDA Plant at Dehradun. Faced all US FDA Inspections of Dehradun plant sucessfully and won 3 consecutive approvals for the plant in the span of 10 years with the Company.
Mumbai Area, India
Team Leader responsible for Regulatory Submissions of TB and MDT Range of Sandoz products in all countries worldwide and Management Representative for Transfer of the Sandoz Products from Austria and Netherland to India.
Mumbai Area, India
Techno-commercial responsibility for API and Formulations.. Head of API Regulatory and DMF filing. Corporate Auditor for Formulations plant, API plants, R&D and Intermediate plants. Responsible for USA and other Regulated markets w.r.t technology transfer and Strategic Planning.
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Mini Vijay Kumar works for Consultancy services.
Mini Vijay Kumar is listed as Pharmaceutical Corporate Quality and Regulatory professional at Consultancy services.
Mini Vijay Kumar is based in Mumbai, Maharashtra, India while working with Consultancy services.
Mini Vijay Kumar has worked for Consultancy Services, Sidmak Laboratories (I) Pvt. Ltd., Sandoz, and Ipca Laboratories Limited.
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Mini Vijay Kumar holds Chemistry from Graduation In Chemistry From K J Somaiya, Mumbai And Mba From Itm Under Articulation With New Hampshire, Usa..
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