Jyoti Thorat
Regulatory Affairs Executive @Bliss GVS Pharma Ltd.
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WORK HISTORY
Regulatory Affairs Executive @Bliss GVS Pharma Ltd.
Mumbai, IN
EDUCATION
Bharati Vidyapeeth College of Pharmacy
M.Pharm
S. G. M. College Karad
High School
ABOUT JYOTI THORAT
An astute professional with 7 + years’ invaluable experience in Regulatory Affairs. Pharmaceuticals (Parenterals & Solid Oral Dosage forms) Products CMC-Regulatory affairs (new submissions in CTD/ACTD/non-CTD formats and Deficiencies response submissions, Post approval changes) for Parenterals & Solid oral dosage forms to Australia, South Africa, MENA (UAE, Saudi Arabia, Morocco and Tunisia), ASEAN (Thailand & Vietnam) and African countries (Zambia, Zimbabwe, Botswana, Namibia, Kenya, Tanzania, Uganda, Ghana, Ethiopia & Nigeria).2. Collection of CMC documents from CFT teams, documents review followed by compilation of dossier in CTD, ACTD and Country specific format.3. Collection, review and compilation of regional information (Module 1)- Filing of Application forms, Admin documents (Mfg.Lic, COPP & GMP), Prescribing information (PI, SmPC, PIL & Artworks), etc.4. Coordinating with regional teams (distributor or Local representatives) for dossier dispatch, deficiencies/queries receiving and submission of response, post approval change submission etc.
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