Subitha M
Regulatory Affairs Officer @Softgel Healthcare Private Limited
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WORK HISTORY
Regulatory Affairs Officer @Softgel Healthcare Private Limited
Chennai, IN
Preparing and submitting the dossier as per the guidelines, Product registration - New Drug Registration(NDA), Query handling, Site registration, Project handling, Ensure to satisfy the customer need, License applying, Problem Handling, Tender Work, Expertise in handling region (CIS and MENA )
EDUCATION
SRM University
Bachelor of Pharmacy - BPharm
ABOUT SUBITHA M
As a Regulatory Affairs Officer at Softgel Healthcare, my role encompasses the strategic preparation and submission of dossiers, tailored to satisfy stringent regional guidelines, particularly within the CIS and MENA territories. Our team\'s commitment to excellence has enabled us to effectively manage new drug registrations, site registrations, and meticulous query resolution, ensuring customer satisfaction and compliance with regional regulatory frameworks. With a Bachelor of Pharmacy from SRM University, I leverage my educational foundation to contribute to the dynamic field of regulatory affairs. Specializing in medical devices and regulatory documentation, I am dedicated to steering projects to successful conclusions, demonstrating a robust understanding of the regulatory landscape that governs our industry.
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