Madhavi Perala
Hydearabd,Telangana
Summary
Master of Science in Organic Chemistry with 10+ years experience in Regulatory Affairs/ Drug Safety. 10+ years experience in Quality Assurance, Clinical Research, SAE/AE Management, post-marketing drug safety. Expertise in preparing ANDA's, Amendments, Controlled Correspondences, Annual Reports, Periodic Adverse Drug Experience Reports, CBE-30, CBE-0 and Post-Approval Supplements for multiple dosage forms to the FDA in a timely manner. Comprehensive knowledge in current Good Manufacturing Practices (cGMP), such as 21 CFR 210/211, FDA Guidance, and ICH guidelines. Experience in Opening and Closing of Quality Systems as required. Review and Approval of Regulatory documents. Working experience with drug safety databases and performing medical coding using MedDRA and WHO-drug dictionaries.
Overview
13
13
years of professional experience
Work History
Regulatory Affairs Associate/Quality Assurance Associate
Chiral Biosciences Ltd
08.2020 - 07.2023
- Compile and submit of Abbreviated New Drug Application (ANDA), prior Approval Supplements, CBE-30, CBE-0, PADER and annual reports in Electronic Common Technical Document (eCTD) format to US FDA
- Handle Queries Related to Dossiers from regulatory authorities and client queries
- Review of Technical documents Like Standard Operating Procedures, Standard Testing Procedures, Batch Manufacturing Records, Specifications, Stability protocols & Art works
- Coordinate with external vendors for project support activities
- This includes collecting and reviewing RS statements, TSE/BSE statements, Melamine free certificates, cGMP certificates, Debarment certificates, US agent letters, DMF LoAs, Technical data sheets and technical drawings, Quantitative compositions of colors, flavors
- Ensure that the quality, content and format of submissions comply with FDA Regulations and Guidelines
- Assist Regulatory Labeling Manager by developing, reviewing and revising labeling documents
- Review DailyMed, FDA’s Orange Book for product information and assist in creating and modifying Structured Product Labeling (SPL) for FDA submission
- Prepare controlled correspondences to the FDA
- Coordinate with external vendors for project support activities
- Extend complete technical support to the business team, by submitting the Dossiers for Registration to obtain market approval
- Assess and triage adverse event reports according to seriousness, expectedness and reportability
- Assess and triage incoming adverse event reports and prioritize them according to the time frames stated in SOP’s as per the company and regulatory requirements
- Submit ICSR via safety reporting portal and perform medical coding in MedDRA and WHO-drug dictionaries
- Compose and review SAE and AE medical narratives for marketed products
- Submit literature articles to applicable regulatory authorities
- Track submission dates for any ICSRs submitted via MedWatch as well as aggregate report submissions
- Aggregate reports preparation and submission like periodic adverse drug experience reports (PADERs)
- Monitor Medical Literature and perform periodic reconciliation of reports
- Review and organize CMC section of Drug Substance and Drug product
- Also review other documents like DMF, COA (Certificate of Analysis), MFC (Master Formula Card), MPC (Master Packaging Configuration) vendor's information, Letter of Authorization (LOA) used in FDA submissions
- Creating Draft Labeling for ANDA submission according to RLD's labeling
- Generated NDC (National Drug Code) for the new products as per the Company’s internal coding system
- Responsible for reviewing batch production records, specifications and final release for distribution
- Additionally responsible for ensuring cGMP practices are performed to assure product quality is consistent with established standards and in compliance with regulatory and industry expectations
- Monitor and track open Incident Reports, Deviations and associated CAPAs for closure
- Assist with writing and review of Standard Operation Procedures as needed
- Ensure all employees are informed and trained on new SOPs and their updated versions
- Daily Processing of Quality Systems (CAPA, Deviation, Investigation, Change Controls, etc.)
- Provide support during FDA audits
- Maintain incoming and outgoing controlled document database and archival system such as SOPs, Forms, Validations, Deviations, etc
- Set up and maintain updated binders with SOP's, Forms, etc
- For employee's reference in their work area
- Incoming material inspection, inventory management and coordination with supply chain management
- Also worked as IPQA when necessary, responsibilities included sampling, line clearances, in process inspection, dispensing, Raw material and finished product release, Maintain Stability data
- Manage temperature and humidity chart recorders with traditional charts and using data loggers (Electronically)
- Provide Guidance to warehouse personals to maintain raw materials and packaging materials.
Regulatory Affairs Associate
Chiral Biosciences Ltd
08.2010 - 07.2017
- Experience in proofreading of labeling (i.e Package Inserts, Medication Guides, packaging, cartons, container labels) to ensure accurate use of grammar, style, content and compliance with established department standards/procedures; initiate change control requests, prepare documents for submission
- Reviewed FDA.gov for RLD (Reference Listed Drug) updates, compare to current labeling, initiate change controls and work with teams to coordinate submissions
- Participate in Promotional Review Committee meetings as regulatory representative for certain product initiatives
- Reviewed change control documents, batch records, stability reports and validation reports
- Prepare submissions to the FDA and other regulatory agencies based on information collected from various departments with in the company
- Assisted in compiling and preparing ANDA based on eCTD format in accordance with FDA Guidelines.
Education
Master of Science - Organic Chemistry
Kakatiya University
Warangal, IndiaBachelor of Science - MPC
Kakatiya University
Warangal, IndiaSkills
- Regulatory/Quality Assurance skills: ANDA, cGMP, Quality Systems, Extedo eCTD manager, Pharma ready SPL
- Drug Safety skills: Safety Reporting Portal, Argus safety database, MedDRA, WHO-drug dictionary Coding, ICSR, SAE processing, Case narratives
- Software skills: MS Office, Excel, Outlook, Word, Power Point
Timeline
Regulatory Affairs Associate/Quality Assurance Associate
Chiral Biosciences Ltd
08.2020 - 07.2023
Regulatory Affairs Associate
Chiral Biosciences Ltd
08.2010 - 07.2017
Master of Science - Organic Chemistry
Kakatiya University
Bachelor of Science - MPC
Kakatiya University
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