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Navyasree Kudithipudi PHONE NUMBER AVAILABLEPlano, TX EMAIL AVAILABLERegulatory Affairs Associate with over 3 years of experience filing high-quality regulatory submissions, interacting with regulatory agencies and project teams concerning submissions, to ensure that all requirements are met.EXPERIENCEObagi Medical, The Woodlands, TX. March 2023  December 2023 Regulatory Affairs Associate Reviewed and evaluated scientific data, analytical methods and reports required for product development and submission in regulatory application. Maintained the current information database for all raw materials, formulations, and finished products. Communicating with FDA and other regulatory bodies regarding submissions. Knowledge and Experience in reviewing ingredients for regulatory compliance for different markets and product categories. Organized and maintained all files related to regulatory actions. Monitored Regulatory environment for changes to requirements. Prepared, reviewed, analyzed, and filed appropriate regulatory documentation. Maintained electronic database for tracking and updating design file documentation. Enforced regulatory affairs department compliance with agency requirements. Interact with internal marketing, R&D, QA, and Project manager to provide support to currently marketed products as necessary and for new product development. This includes reviewing labeling, Product changes and documentation. Working with manufacturers and ingredients suppliers to acquire all necessary documentation and ensure robust product and raw material library. Hands on experience in using SharePoint and other Microsoft tools to manage dossiers. Hetero Labs Limited, Hyderabad, India. Nov 2020 - June 2021 Regulatory Affairs Officer Obtained comprehensive knowledge about quality operations, GMP compliance/audits, and amendments, stability reports. Supported R&D, Quality and Marketing team to provide regulatory advice. Monitored domestic and global regulatory trends, laws and movements and communicated changes across the organization. Preparation, Review and Compliance Module 2 Quality Overall Summery (QOS) and Module 3 Quality (Drug substance) in eCTD format for Regulated and semi regulated Markets for various formulations in API. Review process validation protocol and report along with all the in process checks as per the batch manufacturing records for going to register products. Navyasree Kudithipudi PHONE NUMBER AVAILABLEPlano, TX EMAIL AVAILABLE Review of all CMC documents of drug Substance General information, Manufacture, characterization, control of the Drug substance, reference standard materials, container closure system and stability. Drug Product: Description and composition (Master manufacturing formula), drug development, Manufactures (Batch manufacturing record), control of excipients/ and drug product (Specification, COAs, manufacturers details etc.) Batch packing record and stability data (Pre-stability and post stability assurance letters) Highlight the regulatory issues that can be there and try to resolve them. Review the process change proposals and provide guidance on change proposals. Generating PDF output and XML backbone. Liaise with internal and external teams related to file management and regulations. Submitting annual Amendments to USFDA and European countries. Arene Life science Limited, Hyderabad, India. April 2019 - Oct 2020 Regulatory Affairs Trainee and Officer Experience and knowledge in the preparation of major regulatory submission. Assisted in dossier preparation and submission for USFDA, EMA WHO and some global countries. Assisted in Responding to clarifications from European countries in a timely and accurate manner. Compliance check report documents according to the client specific PDF and MS word specific guidelines. Maintains familiarity with process related standard operating procedures and work instructions. Liaised with cross-functional areas within the organization and associated companies to facilitate timely filing of Regulatory submissions. Confirm that formatting, numbering, and styles and all contents of a published document are in accordance with ICH/FDA guidelines to assure document is submission ready, where applicable. Provide quality-control (QC) check of documents, formatting for compliance with client- specific formats and providing feedback on needed changes to writers. Review QC documents like Analytical method validation (HPLC, STP, SOP, deviation & Stability data). Reviewed and conducted gap analysis on sponsor/supplier provided documentation, including, certificates, product specifications, certificate of analysis, finished product specifications for compliance with regulations.Navyasree Kudithipudi PHONE NUMBER AVAILABLEPlano, TX EMAIL AVAILABLEEDUCATIONMasters in Regulatory affairs - Scient institute of pharmacy, Hyderabad, India Bachelor of Pharmacy - Sarojini Naidu Vanita Pharmacy Maha Vidyalaya, Hyderabad, India SKILLS Experience with CTD/eCTD preparations. Work is performed under consultative direction towards corporate regulatory goals and objectives. Experience in Pharmaceutical production and quality assurance. Records accuracy, Time management and Effective Multitasking. Self-motivated, assertive and acts with sense of urgency and passion.