Himmat Parmar

• Preparation & submission of variation applications for the Europe and Global ROW Markets
• Strategy planning for categorization of the changes proposed during life cycle management of product, Timely submission of variations, queries (RFI), and maintaining regulatory database
• LCM activities in different tools like Global change control, RegPoint, Trackwise, CEDMS, Symphony, document repository tool, etc
• And preparing of Clinical Trials Application packages
• Improve project efficiency, results, or team performance
• Document Management: file transfer, storage, tracking, and archival
• Review of raw data from the manufacturing site, batch records, protocols, CoAs, Specs, analytical procedures, container closure, Stability data, and administrative documents
• Review, compilation, and submission of various post-approval submissions including responses to queries for various clients
• Liaison with in-licensing partners / dossier providers & maintain relationship for consistent support & co-operation
• Respond promptly to comments received from health authorities during variation filing
• Maintain status/tools for all approved/ filed/ ongoing products
• RegPoint, Trackwise, CEDMS, Symphony, Document repository tool, etc
• Clinical Trials Information System, J-tracker, Dossplorer, Veeva Vault RIM software Truvault, Truviewer
• Electronic submissions through CEDMS, Lorenz for US, Europe and ROW Markets
• Management of Regulatory Projects and Operations for US, Europe and ROW Markets

Compilation and submission of registration dossier for regulated market of US/EU and ROW countries in CTD format through various regulatory submission procedures

• Follow-up and review of the administrative data for submission
• Liaison with in-licensing partners/providers & maintain relationships for consistent support & cooperation
• Compilation of dossier from Module 1 to 3, publishing, validation, and submission of registration dossier in eCTD format
• Respond promptly to comments received from health authorities during registration procedures for submitted ANDA and Variations
• Maintain status of all filed/ ongoing products
• Strategy planning for categorization of changes proposed during life cycle management of product, Timely submission of variations, queries (RFI), and to maintain regulatory database
• Review of raw data from manufacturing site, batch records, protocols, CoAs, Specs, analytical procedures, container closure, Stability data, and administrative documents
• Review, compilation, and submission of various post-approval submissions including responses to queries for various clients
• Compilation and timely submission of Annual Reports, supplements (CBE, CBE 30 and PAS) to approved NDA/ANDA to agency
• Compilation of regulatory dossiers and variations for African Countries like South Africa, Sub- Saharan Africa Region, Saudi Arabia, United Arab Emirates, and APAC countries like Singapore, Malaysia, Myanmar, Hong Kong, etc
• Review of executed data from manufacturing to be submitted along with submission
• To perform complete regulatory assessment (Gap Analysis) of available data and share report with clients along with inputs/ suggestions related to submission
• To handle Regulatory document management systems: REGSTAR, DOC-EXECUTIVE, EDUCE, SAP, QAMS, LMS, DMS.CEDMS, Symphony, ARIS, Trackwise, Veeva Vault , RIMS software, Truvault
• Preparation of Regulatory SOP’s and Timely completion of GMP, Functional and EHS Training.