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renuka
Regulatory Affairs Assistant
Contacto
Competencias
Demonstrated experience with Sterility testing.
Demonstrated experience with Bioburden analysis.
Demonstrated experience with Endotoxin testing.
Demonstrated experience with Dossier preparation.
Demonstrated experience with CTD/eCTD submissions.
Educación
Idiomas
Resumen
Regulatory Affairs Assistant open to new opportunities
Experiencia
Regulatory Affairs Assistant
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
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
Implemented and managed affiliate marketing campaigns.. Merged expertise in affiliate marketing with medical content writing.. Conducted data analysis for strategic marketing initiatives.