Regulatory Affairs Global

LAHARI EDAM Findlay OH ***** 774-***-**** ****.*******@*****.***

PROFESSIONAL SUMMARY

Dedicated Regulatory Affairs Specialist with experience in managing regulatory documentation and supporting submission processes, including eCTD, IND, and MAA submissions. Proficient in coordinating and executing documentation preparation and electronic archiving under managerial oversight, ensuring compliance with regulatory standards. Adept at cross-functional collaboration to support regulatory filings, assist with global regulatory team interactions, and facilitate communication with regulatory authorities. Skilled in using Veeva Vault RIM, Adobe Acrobat, Kanban and Office 365 for document management and regulatory correspondence. SKILLS

• Regulatory Documentation & Submissions: IND, CTA, MAA.

• Global Regulatory Compliance: FDA, ICH guidelines.

• Regulatory operations: Preparation, publishing, reviewing, archiving and QC of regulatory documentation.

• Administrative & Project Support: Coordination with cross-functional teams, submission tracking.

• Technical Writing & Editing: eCTD Document formatting, review, and editing for regulatory compliance.

• Regulatory Tools & Systems: EDMS, Veeva Vault RIM, GRACE, Adobe Acrobat, Kanban, Office 365.

• Communication & Collaboration: Effective interaction with regulatory teams, agencies, and partners.

• Quality Control: Document quality checks, compliance with global standards. WORK EXPERIENCE

Jr. Healthcare Data Analyst - Wizcom Corporation – United States 03/2024 – Present

• Created and maintained data reports and dashboards for management, supporting clinical and operational decision-making.

• Collaborated with cross-functional teams to ensure data accuracy and integrity and assisted in the development and implementation of data management protocols.

• Analyzed healthcare data to support clinical and operational decision-making.

• Developed templates and input data into electronic health record (EHR) systems, including eClinicalWorks (ECW), to ensure up- to-date record management and archival purposes.

• Identified and followed up on inconsistencies, errors, and missing information within transcribed reports.

• Worked in a fast-paced, high-volume environment, contributing to improved consumer experiences.

• Ensured patient confidentiality and compliance with legal requirements within ECW.

• Performed additional tasks such as revising patient history and entering medical reports into EHR systems, including ECW. Regulatory Affairs Specialist - GlaxoSmithKline - Pharmaceutical Manufacturing- India 06/2021 – 06/2022

• Led publishing activities as the designated Submission Specialist, QC reviewer, correspondence content provider.

• Reviewed and archived Global Regulatory Application Registration Forms (RARF).

• Stored eCTD and NeeS (IND, NDA, ANDA) in a validated cloud environment using Veeva vault system and linked health authority correspondence to relate submissions for a complete view of regulatory communications.

• Developed and maintained Application, Regulatory objective (RO), submission Objective (SO) activities in Veeva vault.

• Performed Quality Check for Health authority correspondences (HAC QC) in Veeva Vault.

• Ensured quality, accuracy, compliance with the internal & external standards and the timely production of submission documents using EDMS.

• Oversaw and maintained the lifecycle of marketing authorizations (National/MRP/DCP) and regulatory submissions (Renewal, License cancellation, Variation, New file) in the regulatory information system.

• Maintained regulatory files and tracking databases as required and communicated with regulatory agencies as needed. Regulatory Affairs Associate - Tata Consultancy Services Limited - India 12/2020 – 06/2021 Tata Consultancy Services Limited - India

• Compiled, reviewed, and archived regulatory documents to support submission and correspondence to various markets.

• Created Agency Communication Records and Imported submission records in GRACE using integrify request form.

• Provided strategic advice to document owners for archival, ensuring compliance with regulatory standards and procedures.

• Published eCTD submissions, including formatting, hyperlinking, and bookmarking to meet agency requirements.

• Conducted quality checks on published outputs to ensure no unacceptable warnings or validation errors before submission to HA.

• Served as a primary point of contact and RAA coordinator for the RIM team. EDUCATION

• Master of Science in Health Informatics - The University of Findlay – Findlay, OH, USA, Dec 2023

• Bachelor of Science in Pharmacy - Osmania University – Hyderabad, TS, India, Oct 2020. CERTIFICATIONS

• Good Clinical Practices (GCP) - Issued by the National Institute on Drug Abuse (NIDA) - December 2024.

• Six Sigma White Belt - Issued by Council for Six Sigma Certification - December 2024.

• Advanced Post Graduate Program in Clinical Research and Management - Issued by Clini India- August 2021.

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