Summary
Overview
Work History
Education
Skills
Certification
Training
Disclaimer
Projects
Internship
References
Timeline
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RAMYA KUMARI MADHAVARAM

Melbourne,VIC

Summary

Dynamic research associate with extensive experience at Aurobindo Pharma Limited, specializing in CMC documentation and eCTD publishing. Proven ability to enhance regulatory compliance through effective cross-functional collaboration and meticulous gap analysis. Skilled in technical writing and committed to continuous improvement, ensuring high-quality submissions that meet evolving guidelines.

Overview

5
5
years of professional experience
1
1
Certification

Work History

RESEARCH ASSOCIATE - IV

AUROBINDO PHARMA LIMITED
08.2021 - 01.2024
  • Responsible for Preparation, review, compilation and filing of Original ANDAs
  • Preparation, review, compilation and filing of Supplements
  • Authoring and reviewing CMC regulatory dossier for quality part
  • Collecting and reviewing the filing documents from cross functional teams
  • Review of technical documents during product development stage and handling of pre-submission activities
  • Responding to queries received from cross functional teams or regulator agency
  • Ensure to implement changes as per updated guidelines and requirements to improve quality of documents for filing
  • To connect with cross functional teams for successful compilation of dossier
  • Performing gap analysis from the documents submitted and preparing a summary to address the gaps identified
  • Work closely with publishing team for better perspective of regulatory operations, to understand the activities involved in eCTD publishing

ASSISTANT MANAGER

CIPLA LTD
07.2019 - 01.2021
  • Review of pack insert and artworks
  • Submission of applications to regulatory agency
  • Providing support in preparation and Compilation of Dossier
  • Coordination with cross functional departments in responding to the queries received from regulatory agencies.

Education

Master of Pharmacy - Medicinal And Pharmaceutical Chemistry

Birla Institute of Technology And Science
01.2019

UG -

Bojjam Narasimhulu Pharmacy College for Women
Hyderabad
01.2017

CLASS XII -

Sri Chaitanya Junior Kalasala
01.2013

CLASS X -

Vivekananda High School
01.2011

Skills

  • ICH guidelines
  • Microsoft PowerPoint
  • Microsoft Excel
  • Microsoft Word
  • Various chromatographic techniques
  • Literature review
  • Data collection and organization
  • Regulatory compliance
  • CMC documentation
  • eCTD publishing
  • Technical writing
  • Gap analysis
  • Cross-functional collaboration
  • Document review
  • Effective communication
  • Attention to detail
  • Problem solving
  • Time management
  • Detail-oriented
  • Qualitative research
  • Quality assurance standards
  • Time management abilities
  • Continuous improvement

Certification

  • Talent of the month receiver
  • Six Sigma - Yellow belt by Skillsoft
  • Introduction to FDA Human Drug Review and Approval Basics by FDA
  • Generics Drug Overview by FDA
  • Abbreviated New Drug Review Process by FDA

Training

  • Innovations in pharmaceutical research, Presented Scientific poster paper entitled 'An Antibody Drug Conjugate-KADCYLA', 07/01/14
  • Pharmacist: caring for you, The Indian Pharmaceutical Association, Telangana state branch, 08/01/16
  • Reforms and innovations in pharmacy education towards global standards, Center for Pharmaceutical sciences, IST and APTI, 02/01/15
  • An International Seminar on Significance of Provider Status for the Practice of Pharmacy, ACPI, KSPOR and Sultan-ul-uloom College of Pharmacy, 06/01/15
  • Apollo Life Savers Program, Apollo med skills

Disclaimer

I hereby declare that the details furnished above are true and correct to the best of my knowledge and I am aware that I may be held liable for it.

Projects

Design and Synthesis of cationic peptidomimetics as antimicrobial agents - Peptidomimetics, 01/01/18 - 12/31/18, To combat the drug resistance of existing antibiotics, peptidomimetics would play important role as antimicrobial agents. Cationic peptides have a capability to show antimicrobial activity by the lysis of cell membrane of bacteria and are amphiphilic in nature. Peptidomimetics were synthesized using Ugi reaction which is a multicomponent reaction. Antihyperglycemic effect of short-term resveratrol supplementation in type-2 diabetes patients-Resveratrol effects, 12/01/16 - 04/30/17, Performing formulation development trails and co-ordinate with the analytical research team for the analysis and results. Working with scientists in developing various dosage forms. Preparing presentations and Compilation of data. Report directly to a R&D Formulation Manager.

Internship

IQVIA, TRAINEE ANALYST, 01/01/19 - 06/30/19, Performed Secondary Desk Research, Provided business insights after analyzing reports and data, Learnt different models of forecasting, Supported the clients in understanding business strategies in health care sector

References

References available upon request.

Timeline

RESEARCH ASSOCIATE - IV

AUROBINDO PHARMA LIMITED
08.2021 - 01.2024

ASSISTANT MANAGER

CIPLA LTD
07.2019 - 01.2021

Master of Pharmacy - Medicinal And Pharmaceutical Chemistry

Birla Institute of Technology And Science

UG -

Bojjam Narasimhulu Pharmacy College for Women

CLASS XII -

Sri Chaitanya Junior Kalasala

CLASS X -

Vivekananda High School
RAMYA KUMARI MADHAVARAM