Sandhya Burada

Seeking a challenging position in Regulatory Affairs where I can use and apply my knowledge and skills in Regulatory submission and understanding of the Regulatory quarries and helping to the organization success.

Working as an Apprentice - Dr.Reddy's laboratories Ltd, IPDO, Bachupally - Hyderabad

• Understanding of all major markets USFDA, CDSCO, European union, MHRA, T.GA and other semi regulatory markets.
• Documentation and regulatory writing of eCTD, CTD submissions
• Good knowledge in NDA, ANDA, INDA, MAA and DMF submissions
• Good Knowledge in DMF, ASMF filing with respective to USFDA, European Union and other semi regulatory agencies
• Effectively managed regulatory dossier activities including planning, formatting, compilation and review
• Understanding of ICH guidelines
• Keeping My self updated to the current regulatory guidelines
• To Perform analytical method Validations of Assay and Dissolution by using HPLC for various dosageformsl like solid Oral Dosage forms (Tablets, Capsules).
• Working as part of the Analytical R&D team with hands on experiencein Pharmaceutical analysis. Like Dissolution, Assay, UOD, BA, BU, Water Content (KF).
• Proficient in handling of Essential Software tools such as Empower, LIMS & Tiamo2.5 (KF).
• Performing Daily, Monthly and halfyealy Calibrations of analytical instruments including HPLC, Dissolution pHmeter, and Analytical balances.
• Good knowledgeinICHguidelinesandDataintegrity & ALCOA++ principles
• Performing Analysis by Following cGMP, GLP, GCP & GDP regulations and laws

Master of sciences - chemistry - ACHARYA NAGARJUNA UNIVERSITY (2022-01 - 2024-12)

Bachelor of sciences - chemistry - DR.B.R AMBEDKAR UNIVERSITY (2019-01 - 2022-12)