Navya sree Kudithipudi +1-918-***-****
**** ******* **, *** *** adz0xw@r.postjobfree.com
The Woodlands, TX 77380
EXPERIENCE
Obagi Medical, The Woodlands, Tx.
Regulatory Affairs Associate March 2023 – Continuing
• 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.
• 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. Hetero Labs Limited, Hyderabad, India. Dec 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) 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.
• 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. Navya sree Kudithipudi +1-918-***-****
2495 Sawdust RD, Apt 808 adz0xw@r.postjobfree.com The Woodlands, TX 77380
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.
• Reviewed and conducted gap analysis on sponsor/supplier provided documentation, including, certificates, product specifications, certificate of analysis, finished product specifications for compliance with regulations.
EDUCATION
Scient institute of pharmacy, Hyderabad, India - Masters in Regulatory affairs. SKILLS
• Self-motivated, assertive, self-confidence and acts with sense of urgency and passion.
• 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.