Regulatory Affairs Product Development

Navyasree Kudithipudi +1-918-***-****

Plano, TX *******************@*****.***

Regulatory 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.

EXPERIENCE

Obagi 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 +1-918-***-****

Plano, TX *******************@*****.***

• 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 +1-918-***-****

Plano, TX *******************@*****.***

EDUCATION

Masters 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.

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