Reddy Sri Sai Amrutha
Regulatory Affairs Officer @Sri Krishna Pharmaceuticals Ltd.
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WORK HISTORY
Regulatory Affairs Officer @Sri Krishna Pharmaceuticals Ltd.
Hyderabad, IN
Compilation of eCTD and ACTD Dossiers for solid oral dosage forms and DMFs (DC granules)*Handling of queries received from customers or regulatory authorities on time *Coordinating with cross functional teams for effective completion of the projects.*Submitting dossiers/variations using Pharmaready software after validating in Lorenz Evalidator.*Review of manufacturing documents like BMR, BPR and process validation protocols and report, hold time study protocols and other necessary documents like PDR for Regulatory submissions.*Review of Analytical documents like Specifications, STPs and CoAs of Raw materials, packaging materials and Finished products*Review of Analytical Method Validations or Verification protocols and reports required for submissions.*Review of Stability data including In-use stability and photo stability data.*Responsible for review of Annual Product Quality Review.*Preparation and review of SmPC, PIL and leaflets.*Review of Artworks, initiation of change controls.
EDUCATION
Bala Vignana Mandir (E.M) School ,Rajahmundry
SSC
Vikas institute of pharmaceutical sciences
Bachelor of Pharmacy - BPharm
Vikas institute of pharmaceutical sciences
Master of Pharmacy, Regulatory Affairs
Mathrusri junior college
Intermediate , Bipc
ABOUT REDDY SRI SAI AMRUTHA
Entry-Level Regulatory Affairs Professional with a strong foundation in pharmaceutical regulations and compliance. Possess excellent problem-solving skills and a keen eye for detail. Eager to contribute to a dynamic team and support regulatory submissions, documentation, and compliance initiatives. Demonstrated ability to quickly learn and adapt to new regulatory environments. Committed to ensuring the highest standards of quality and safety in the pharmaceutical industry. Passionate about pursuing a rewarding career with a multinational company to gain valuable global exposure and make a meaningful impact
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