Swathi Rapaka yh GB

Currently seeking a new and challenging position for a leading pharmaceutical organisation, utilising gained M. Pharmacy degree in Pharmaceutics along with professional experience in Regulatory Affairs that will enable the achievement of further professional and personal goals.

Delivery Associate-RA - Fresenius-Kabi India Pvt. Ltd - Gurugaon

(2024-12)

• Compilation in submission of post approval changes to EU authority as per up to date guidelines and country requirements
• Timely authoring (M1), compilation and publishing of submissions for variation applications.
• Update of Kabi RegTrack (Software) and tracking tool for related regulatory submissions on respective software's.
• Tracking and informing the daily basis updates from EMA site on EU guidelines as Regulatory Intelligence role.
• Careful review of the documents for its regulatory adequacy and scope before implementation in the dossiers.
• Also categorization and preparing the documentation for AU post approval changes as per the requirement of TGA.

Executive- Regulatory Affairs - MSN Laboratories Pvt. Ltd - Hyderabad

(2022-04 - 2024-12)

• Compilation of CMC quality modules in eCTD for EU regulatory agencies through various procedures.
• Have best awareness on ICH guidelines.
• Initial dossier preparations & submission through respected country portals.
• Review of Various documents like BMR, specification, Validation protocols & Validation Reports, Stability protocol, Elimental impurity report, Nitrosamine report, CDP, PDR, stability data, MPC, BPR & all other documents related to regulatory submissions.
• Handling and finalizing of modules from M1 to M5
• Compilation in submission of Variations, Handling of change controls in QAMS.
• Updating the dossiers (M2 & M3) as per customer requirement in EUROPE Market.
• Review of M1 documents.
• Preparation and review of Product approval package for plant and respective batch release sites.
• Careful review of the documents for its regulatory adequacy and scope before implementation in the dossiers.
• Coordinate effectively with cross functional teams and external parties in identifying and obtaining documentation and information for regulatory submissions.
• Updating regulatory databases as per the performed activity.
• Preparing Monthly status report.

Master of Pharmacy - Pharmaceutics - Gurunanak institutions of technical campus (2018 - 2020)

Bachelor of Pharmacy - Balaji institutions of pharmaceutical sciences (2014 - 2018)

Intermediate - B.I.P.C - Govt. Junior college, Narsampet (2012 - 2014)

SSC - ZPHS high school Narsampet (2011 - 2012)