Nargarjuna Gindam

Regulatory Affairs Associate

Email: ac7xsi@r.postjobfree.com

Ph: 978-***-****

SUMMARY

Comprehensive understanding of FDA’s, MHRA’s, European Medicines Agency’s organization and its contemporary regulatory compliance proceeding processes.

Experience in regulatory compliance and quality assurance.

Experience in establishing and developing regulatory affairs and Quality assurance systems.

Ability to make effective use of regulatory intelligence in designing regulatory strategy for commercialization of product in emerging markets.

Ability to prepare 510(K) submissions and carry out successful 510(K) submissions to the FDA

In-depth knowledge of FDA regulations for GCP’s, GLP’s, GMP’s.

Knowledge of US and International regulations for regulatory approval of products.

Knowledge and understanding of the development process of eCTD submissions.

Skills

CTD filings/guidelines

Drug Master Files (DMFs)

Review of Quality control documents

FDA guidelines

ICH guidelines

Project Tracking

Document Compliance

PROFESSIONAL EXPERIENCE

MERCK & Co. Inc, Durham, NC Nov 2017 – Till date

Regulatory Affairs Specialist

Manage product lifecycle focused on planning and executing development, CMC review, and submission.

Coordinate with cross functional teams like R&D, QA, supply Chain, Logistics and Manufacturing units and manage accountabilities in long term projects for high quality dossier preparation.

Direct and coordinate the dossier preparation (operations/ publishing), review and submission of ANDAs, 505(b) 2 and DMFs.

Build strong relations and Interact with FDA personnel regularly to expedite approval of pending application and to resolve outstanding regulatory matters.

Perform regular product labeling and patent exclusivity review for all marketed products and manage development of commercial artwork for new product launches.

Responsible for review and oversight of post-approval promotional and advertisingmaterial (AD-Prom) including sales aids, training material and commercial product labeling.

Responsible for development of new processes and design SOPs for regulatory affairs and compliance.

Regulatory due-diligence and market research for the US generic drug trends including Paragraph IV certification products.

Regulatory upkeep based on the current regulations and understanding of the FDA and pharmaceutical Industry.

Continuous process improvement to streamline global teams and aligning the procedures for regulatory management.

C.R. Bard, Covington, GA Oct 2015 – Oct 2017

Regulatory Affairs Associate & Quality Control Chemist

Co-ordinate with Regulatory working groups to provide requirements for regulatory submissions by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy within timelines.

Assisted in the analysis and documentation of regulatory submissions and conducted regulatory research with guidance from the Regulatory Manager

Assisted in the compilation and organization of materials needed for regulatory submissions, administration of documents and maintained regulatory files and assisted in writing regulatory SOP’s

Reviewed sections of eCTDs. Followed up with the respective teams with regards to the information noted within eCTD sections

Ensured compliance with all internal processes and SOPs related to submission activities.

Communicated within the organization to provide regulatory strategy and offered creative solutions and strategies.

Ranbaxy Laboratories, Hyderabad May 2013-Aug 2015

Regulatory Affairs Associate

Coordinating with colleagues at different geographies e.g,FDA/EU/AUS/NZ/RSA to ensure submission of quality response to regulatory queries on new products submissions / variations, within the time lines of the Health Agencies.

Reviewing regulatory documents (specifications, stability protocols, process validation reports, batch manufacturing records, packaging documents, stability data etc.) required to be submitted to the Health Agencies in support of the new product submission / variations and response to queries.

Reviewing site transfer documents like Product Transfer Document and finalizing the variation strategy to file the site transfer variations.

Reviewing change controls and studying the regulatory impact of the proposed and finalizing the variation strategy.

Reviewing the change controls and giving regulatory comments using TrackWise.

Reviewing documents received from different third-party companies/clients against regulatory requirements.

Coordinating with cross-functional departments like R&D, manufacturing, clinical research, external clients etc., to ensure the quality and timely new product submission / variations and response to queries to Agency.

To keep a track and follow up for the documents required for new product submission / variations and response to queries.

EDUCATION:

Master of Science in Chemical Engineering from University of Massachusetts, Lowell, MA

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