MUTHYALA PRANEETH KUMAR

Over 6+ years of Rich Experience in Regulatory affairs and previously 3 Years experience in AR&D. Qualified in M. Pharm (Pharmaceutics) from CVSR College of pharmacy currently associated with Merck Specialties Pvt. Ltd. as Specialist -Regulatory Affairs, Exposure in US, EU, Canada, GCC, and other global Markets for handling post approval submissions, IND, CTA, MAA & Renewals. Life cycle management of product, planning of submissions, conducting KOM's, document request co-ordination for timely receipt of the documents. Handling of queries and timely submission of the response.

• Senior Specialist in submission of dossier to Global regulatory markets. (Solid orals, Oral Solutions)
• Research Associate in Formulation Analytical Research (Parenteral Formulations, solid orals)

• Planning of submissions, conducting KOM's for Renewals, Variations, MAA and AtO's. As per country requirements requesting admin documents, request co-ordination for timely receipt of the documents from contributing functions CMC, local documents from CRA. Handling of queries and timely submission of the response. Timely update of submission tracker. Handling Veeva-vault document management system.
• Manage and execute planning, compilation and dispatch of submissions to Health Authorities during the application lifecycle.
• Managing working relationships with key stakeholders, Extend support on strategy and submissions in distributor managed markets. Extend support on HA advocacy whenever required.
• Responsible for maintenance of National/MRP/DCP procedures of different products and submitting variations to agencies in eCTD format via CESP portal submission.
• Managed and oversaw ad promo submissions for the US market, including the review, compilation, and submission of approximately 150 promotional materials, ensuring strict adherence to regulatory guidelines and company standards.

• US Regulatory Market (ANDA), Canada Regulatory Market (ANDS), EU Application Compilation (Module M1, M2, M3), review and submission.
• Preparing the Module 1, Module 2 and Module 3.
• Review the Modules as per the RTR checklist for US ANDA submissions.
• Publication and validation of dossiers using eCTD dossier management publishing tool (Educe, Pharma ready).

• PPD Repatriation - Over the past two years, we have successfully built a solid foundation for a seamless knowledge handover.
• Rollouts-We have successfully performed three rollouts, contributing to the expansion and enhancement of our projects.
• EAEU: Our pilot products, have been submitted successfully to health authorities in the Eurasian Economic Union (EAEU).
• Spotlight Award - In November 2022 received recognition 'Spotlight award" for leading the way category.
• Promotion: Promoted as senior specialist in 2024.

• Father's Name: M. Rajashekar
• Mother's Name: M. Devahuthy
• Date of Birth: 06/27/1990
• Gender: Male
• Nationality: Indian
• Marital Status: Single

• Performing product validation as per the requirement for regulatory markets
• Performing supplement validation:
• Changes or updates in USP.
• Change in excipient in the formulation.
• Development of stability indicating analytical methods for assay, Related substances for finished products by HPLC.
• Preparation of Standard Operating Procedures, Standard Testing Procedures.