Pooja Nilendra Kharose

• Worked for Takeda Pharmaceuticals as a Regulatory Submission Publisher.
• Ensure regulatory submissions are prepared, formatted and delivered to Health Authorities in compliance with applicable regulations, guidelines and technical standards.
• Perform document formatting and quality control, eCTD management, regulatory compliance, submission delivery and lifecycle management.
• Use DocuBridge and Veeva Vault (ERV) in regulatory submission publishing activities.
• Support submission activities with understanding of FDA, ROW and ICH requirements.

• As a Document Management Specialist at Tata Consultancy Services (TCS), I have handled projects on ERV (Veeva Vault) for EU/US/ROW markets with eCTD and CTD submissions including pre-publishing, publishing,
  hyperlinking, compilation, validation and dispatch activities.
• My role holds the responsibility of supervising submission which includes a publishing request from Initial phase to dispatch and archival into Repository.
• Publishing requests includes Variations, MA Transfers, MRP-DCP & Renewals.
• Experience of publishing, compilation and validation of eCTD dossier for US market. Publishing of submission including ANDA, BLA, DMF, IND and NDA applications and submitting them to CDER and CBER through ESG portal.
• Hands-on for processing of Marketing Authorization Application (MAA) submissions to EU National, Mutual Recognition Procedure (MRP), Centralized (CP) and Decentralized Procedure (DCP) with Initial, Renewal, Response and Variation (Type 1A,1AIN,1B and 2).
• Efficiently managing regulatory documentation to meet electronic publishing standards,Health Authority guidelines and adhering to Standard Operating Procedures (SOPs) with a100% compliance rate.
• I have good experience of customer handling that includes communicating with Regulatory Affairs Managers (RAM), Dossier Managers (DM), and Marketing Company (MC) personnel, to understand their requirements. I also manage meetings with data stakeholders, country RA presenting the progress and outcomes of the submissions.

• Data collection & authentication from conference & Publication
• Drug research from different sources
• Data extraction from different clinical trial registries
• Good hands-on Pub Med, Clinicaltrialgov, Abstracts, Annual Report
• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.

• Secured 1st Class with 87.95% under Mumbai University.
• Four-month Project in Purification area named as “Purification of Anti-Thymocyte Globulin” at Bharat serums & vaccines Ltd, Airoli, in 2019-20

• Secured 1st class with 75.87% under Mumbai University.
• Research project named as "Isolation & Characterization of Different Nutrients of Hyalocereus Fruit & Study It's Antioxidant Properties" at Pillai’s college in 2016-17
• One-month project training in "Parle Biscuit Pvt Lid" in 2016- 17
• Internship at pathology lab "Aarti Malik's computerized lab" New Panvel under social activity on 2018-19

• Secured 1st class with 77.85% under Mumbai University

• Secured 1st class with 92.36% under Maharashtra Board