AMARJYOTI KALITA

• Responsibility of preparation and submission of regulatory filings to FDA for new product approvals
• Prepared and submitted labeling changes, and post-marketing changes, i.e., CBE 0, CBE 30, and Prior Approval Supplement.
• Coordinated with cross-functional teams to ensure timely and accurate submissions.
• responded to and resolved FDA queries and provided necessary information to support regulatory submissions and receive approvals.
• Reviewed the DMF's for compliance with FDA regulations prior to New product Submissions.
• Responsibility of generation of ANDA and NDA number using CDER Nxtgen portal.
• Well experienced in eCTD activity in Educe application.
• Maintaining Life cycle activities for approved applications, such as PADER reports and Annual reports for the USFDA.
• Reviewed and approved batch records and other quality system documents for compliance with regulatory requirements such as Elemental impurity risk assessment, nitrosamine risk assessment, stability protocols, and APQR.
• Responsibility for the preparation and submission of Control Correspondence.
• • Generation of a GDUFA cover sheet for payment of applications and annual program fees to the FDA
• Drug listing of products, self-identification of establishments, and Establishment registration
• Preparation and Submission under the CARES Act.
• Responsibility for maintaining database activity.

Support data management activities for Elanco Animal Health.
involved in various tasks such as data entry, cleaning, and validation.
learned how to create and maintain databases, ensure data accuracy and integrity, and understand the regulatory requirements surrounding clinical data management.

Support electronic archiving activities for multiple documents.
• Provided training on archiving for new members.
Support the migration of data from legacy databases and sharepoints onto Elanco systems.
Support the Scientific Disclosure process by ensuring the publication package is complete and approved by the mandated stockholders.
Support the quality function by managing deviations and change control track-wise.
Prepare SOPs and checklists for the data management process.

Support data management activities for Elanco Animal Health.
• Databases are built for companion and farm animal studies based on the Elanco data dictionary and data standards.
• Generated databases are built in Microsoft Excel and Electronic Data Capture.
• Transcribing data from paper CRFs and EDC databases
• Peer QC of data entry by direct comparison or double data entry comparison
• Raises flags and queries for erroneous data or outliers.
• Resolves queries with stakeholders to expedite data finalization and database lock.

learned how to create and maintain databases, ensure data accuracy and integrity, and understand the regulatory requirements surrounding clinical data management. Involved in various tasks such as data entry, data QC, cleaning, and validation.