SRAVANTHI Arelly
Regulatory Affairs Specialist
Hyderabad
Summary
Regulatory Affairs Specialist with over 8+ years of experience in handling ANDA submissions, resolving deficiencies, and managing product lifecycle. Includes 2 years of analytical experience. Proven expertise in navigating USFDA and NMPA regulations, ensuring compliance, and delivering timely submissions. Skilled in project management, analytical problem-solving, and cross-functional team collaboration, contributing to the successful launch and maintenance of multiple products.
Overview
11
11
years of professional experience
Work History
Regulatory Affairs Specialist-NMPA (China Market)
Dr. Reddy's Laboratories Limited.
07.2021 - Current
- Successfully prepared, reviewed, and submitted 10 to 12 ANDAs for the China market, effectively addressing and resolving deficiencies identified by the NMPA within 80 working days.
- Managed post-approval changes, including variations, notifications, and annual reports, ensuring compliance with China's regulatory requirements.
- Streamlined change control processes through SAP, enhancing product lifecycle management efficiency.
- Delivered phase gate presentations at each product development stage until filing ensuring clear communication with cross-functional teams and compliance with regulatory expectations.
- Coordinated the closure of dossier filing open points by collaborating effectively with R&D, manufacturing, and analytical teams. Conducted biweekly meetings to track progress ensuring no delay upon receipt of deficiencies.
- Provided regulatory guidance through out the product development process for 15 products ensuring adherence to applicable regulations at every stage.
- Developed technical package and contributed to successful product launches by coordinating with various departments (FRD, ARD, Plant QA, QC) for approved products and actively participated in launch activities.
- Conducted due diligence on dossiers for other markets, leveraging critical insights to enhance the quality and compliance of China market submissions by preparing a comprehensive regulatory strategy document.
- Secured essential administrative documents (manufacturing licenses, WHO GMP, COPPs) for timely dossier filings.
Fellow Regulatory I-USDFA
Graviti Pharmaceuticals Private Limited
08.2016 - 07.2021
- Conducted thorough screening and gap analysis of critical technical documents, ensuring compliance and readiness for filing.
- Successfully Compiled, reviewed, and submitted ANDAs in eCTD format to the USFDA.
- Coordinated effectively with R&D, manufacturing, analytical teams, and API vendors to achieve timely dossier submissions.
- Managed and resolved product amendments and CMC-related deficiencies within the stipulated timeframe.
- Handled Prior Approval Supplements, CBE-30, CBE-0, and annual reports with precision.
- Prepared controlled correspondences and reviewed/approved change controls.
- Provided strategic regulatory support throughout the product life cycle from development to post-approval activities.
- Implemented and Notified post-approval changes ensuring regulatory compliance.
- Managed the lifecycle of approved products and tracked project submissions.
- Provided critical regulatory insights to stakeholders, ensuring informed decisions and timely project completion.
- Implemented regulatory registrations and guidelines.
- Supervised a team of four members, enhancing efficiency in dossier compilations and lifecycle management.
Research Associate-Analytical Research
Graviti Pharmaceuticals Private Limited
09.2014 - 07.2016
- Conducted routine and stability analysis of solid oral formulations, ensuring product quality and compliance.
- Reviewed stability analysis reports and raw data, identifying and resolving potential issues.
- Proficiently calibrated and operated analytical instruments, including HPLC, UV spectrophotometer, and dissolution apparatus.
Education
Master of Science - M. Pharmacy With A Specialization in Pharmaceutics
Kakatiya University
Warangal, India 04.2001 -
Skills
Regulatory Knowledge: In-depth understanding of USFDA and NMPA regulations, guidelines, and submission requirements
Project Management: Ability to manage multiple projects, timelines, and coordinate with cross-functional teams
Analytical Skills: Strong analytical abilities to interpret regulatory guidelines and apply them to product development and submissions
Problem-Solving: Proactive approach to resolving regulatory issues and deficiencies within stipulated timeframes
Communication Skills: Effective communication with regulatory bodies, internal teams, and external stakeholders to provide clear regulatory guidance
Timeline
Regulatory Affairs Specialist-NMPA (China Market)
Dr. Reddy's Laboratories Limited.
07.2021 - Current
Fellow Regulatory I-USDFA
Graviti Pharmaceuticals Private Limited
08.2016 - 07.2021
Research Associate-Analytical Research
Graviti Pharmaceuticals Private Limited
09.2014 - 07.2016
Master of Science - M. Pharmacy With A Specialization in Pharmaceutics
Kakatiya University
04.2001 -
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