Praveen Kumar Namala

Senior Regulatory Operations Associate @Kimberly-Clark

Hyderabad, TG, IN
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2023 — Present

Senior Regulatory Operations Associate @Kimberly-Clark

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Hyderabad, IN

Provide project leadership for the build and management of complex, end-to-end business process solutions to improve regulatory operations and overall GRA processes • Primary liaison with regional global regulatory affairs team to ensure current standards are well understood and integrated into regulatory systems and tools. • Acts as SME and liaison to ensure existing regulatory affairs system interfaces are identified and designed appropriately into the new solutions(s) while considering global activities and requirements. • Process owner leading teams focused on the development of standardized global approaches aligned with industry best practices in regulatory affairs. • Maintains and demonstrates a high degree of knowledge and skill in quality management systems, processes, and regulations. • Supports the creation of systems and tools to add global efficiency and data sharing.• Maintains comprehensive knowledge of applicable regulatory requirements and interpretation. • Provides regulatory compliance expertise by sharing external regulatory environment, industry trends as well recommending actions to address any potential impact to the enterprise.

EDUCATION

2008 — 2010

Manipal Academy of Higher Education

Master of Science (M.Sc.)

2003 — 2007

Osmania University

B. Pharmacy

SKILLS

Electronic Submissions-EctdRegulatory AffairsRegulatory SubmissionsPharmaceutical IndustryRegulatory RequirementsSopValidationGmpClinical TrialsPharmaceuticsFdaMedical Devices21 Cfr Part 11Clinical ResearchEctdCapaGeneric ProgrammingLifesciencesChange ControlStandard Operating Procedure (Sop)Corrective and Preventive Action (Capa)U.s. Title 21 Cfr Part 11 RegulationElectronic Common Technical Document (Ectd)Life SciencesU.s. Food and Drug Administration (Fda)

ABOUT PRAVEEN KUMAR NAMALA

As a Global Regulatory Operations Lead and Subject Matter Expert at Kimberly-Clark, I…

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Praveen Kumar Namala — Senior Regulatory Operations Associate at Kimberly-Clark in Hyderabad, TG, IN | Unifers