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renuka

Regulatory Affairs Assistant

Contato

Mumbai, Maharashtra, India
Disponível na CazVid
Contato pela CazVid

Competências

Sterility testing

Demonstrated experience with Sterility testing.

Bioburden analysis

Demonstrated experience with Bioburden analysis.

Endotoxin testing

Demonstrated experience with Endotoxin testing.

Dossier preparation

Demonstrated experience with Dossier preparation.

CTD/eCTD submissions

Demonstrated experience with CTD/eCTD submissions.

Formação acadêmica

Diploma, Pharmaceutical Regulatory Affairs
Institute of Good Manufacturing Practices India
MSc, Microbiology
Vivekanand Institute of Science And Technology, Mumbai
BSc, Microbiology
Lords Universal College, Mumbai
HSC, Science
Thakur College of Arts, Science And Commerce, Mumbai
SSC
St. Judes High School, Mumbai

Idiomas

EnglishProfessional
HindiNative

Resumo

Regulatory Affairs Assistant open to new opportunities

Experiência

Regulatory Affairs Assistant

Inga Pvt Ltd
Mar 2025 - Nov 2025

Handled regulatory affairs activities for the ROW (Rest of World) market.. Supported dossier preparation and documentation for product registrations across ROW markets.. Coordinated with internal teams to ensure regulatory documentation met country-specific requirements and timelines.. Applied knowledge from the Diploma in Pharmaceutical Regulatory Affairs to real-world submission and compliance workflows.

Analyst

Cipla Pharmaceuticals Ltd
Sep 2020 - Nov 2022

Conducted microbiological water analysis of purified and potable water samples.. Managed standard bioballs and in-house culture activities.. Performed environmental monitoring and microbial limit testing.. Ensured compliance with laboratory protocols and quality standards.

Affiliate Marketing Executive

Logicloop Ventures

Implemented and managed affiliate marketing campaigns.. Merged expertise in affiliate marketing with medical content writing.. Conducted data analysis for strategic marketing initiatives.

Habilidades

Sterility testingBioburden analysisEndotoxin testingDossier preparationCTD/eCTD submissions
Publicado na CazVid - 15 de out. de 2026
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