Dr. saroj kumar roy
Angestellt, Senior Manager - Dossier Management and CMC, Freyr Software Services Private Limited
Hyderabad, Indien
Werdegang
Berufserfahrung von saroj kumar roy
Bis heute 4 Jahre und 4 Monate, seit März 2020
Senior Manager - Dossier Management and CMC
Freyr Software Services Private Limited
• Preparation of regulatory submission strategies for Solid oral dosage forms for EU and ROW • Regulatory assessment of source documents for their adequacy in line with EU requirements • Preparation, review and submission of MAAs • Evaluation of for post approval changes • Regulatory consultation support on client queries
3 Jahre und 8 Monate, Juni 2016 - Jan. 2020
Manager, Drug Regulatory Affairs - CMC
Eli Lilly and Company
Responsibilities: •Planning and managing regulatory submissions for products within Lilly's portfolio in compliance with global filing plans and local regulatory requirements •Authoring high-quality CMC documentation dossier for CTDs (NDA/ MAA) submission for biologics, respecting agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines
1 Jahr und 3 Monate, Apr. 2015 - Juni 2016
Lead, Regulatory Affairs
iMEDGlobal Solution India Pvt. Ltd.
1. Managing CMC regulatory matters related to initial registration, maintenances of business activities, identifying regulatory strategy and filing of post-approval changes globally
2 Jahre und 9 Monate, Aug. 2012 - Apr. 2015
Executive, Drug Regulatory Affairs
Mylan Lab. Ltd. India
Preparing CTD dossiers (Module 1 , 2.3 and 3) for new product submission adhering to the Quality standards and the requirement For Europe, Australia, New Zealand and South Africa
1 Jahr und 7 Monate, Feb. 2011 - Aug. 2012
Consultant
Novartis Healthcare India Pvt. Ltd.
Authoring CMC Modules 3 for IND/IMPD submission and for Variation application package
Ausbildung von saroj kumar roy
4 Jahre und 8 Monate, Mai 2006 - Dez. 2010
Pharmaceutical Sciences
NMIMS University, SPP School of Pharmacy & Technology Management. Mumbai, India
(Pharmaceutical Sciences) Dissertation Topic: Formulation and evaluation of transbuccal drug delivery system using modified acrylate polymers
2 Jahre, Mai 2003 - Apr. 2005
Pharmaceutical Chemistry
Bharati Vidyapeeth University, Poona College of Pharmacy (Pune, India)
(Pharmaceutical Chemistry) Dissertation Topic: Synthesis, antihyperlipidemic activity and QSAR of some condensed 2, 4-dichloro thienopyrimidines
4 Jahre, Juli 1998 - Juni 2002
Pharmacy
Delhi University, DIPSAR (Delhi, India)
Pharmaceutics, Pharmacology, Pharmaceutical Chemistry, Pharmacognosy, Analytical Chemistry and Anatomy & Physiology
Sprachen
Englisch
Fließend
Deutsch
Grundlagen
Hindi
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