Sanjay Nikam
General Manager @ Inventia Healthcare Limited
About
25+Years of insightful experience in Pre & Post Dossier submission and Life Cycle Management related activities. Exclusively worked for US, EU/UK, Australia, Canada Markets. Specialties: Regulatory Affairs, ANDA, eCTD, USFDA, MHRA, TGA, Health Canada, ICH, Generics, Validation, cGMP.
India
Mumbai
Pharmaceuticals
Regulatory Affairs, ANDA, eCTD, Validation, Regulatory Submissions, Generics, cGMP, USFDA
Experience
General Manager
Inventia Healthcare Limited
Thane
Team Leader
Deputy General Manager
Lupin Pharmaceuticals
Mumbai Area, India
Responsible to handled pre/post ANDA submission and Life Cycle Management activities for US Market.
Senior Team Manager
Famy Care Ltd., Mumbai
Navi mumbai
Responsible to handled pre and post ANDA / ANDS submission and Life Cycle Management activities for US / Canada Market.
Scientist-II, Drug Regulatory Affairs (US Market)
Torrent Pharmaceuticals Ltd
Ahmedabad Area, India
Responcible to handled pre/post ANDA Submission related activities for US market.
Sr. Research Associate-Analytical Development and Validation (US Market)
Zydus Group
Ahmedabad Area, India
Responcible for Analytical method development and validation Execuation and Review of Validation Reports.
Analyst- Quality Control
Alembic Pharmaceuticals Limited
Baddi, Himachal Prades
Responcible to handled Raw Material and Finished Product Analysis
Group Leader- QC
Cipla
kurkumbh, pune
Responsible to handled Raw Materials section
Trainee Officer- QA
Rhone-Poulenc Rorer
Aurangabad Area, India
Responsible to handled QA routine activities
Education
Maharashtra University of Health Sciences
Pharmaceutical Sciences
Sanjay Nikam's Contact Information
Phone
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