Summary
Overview
Work History
Education
Skills
Timeline
Generic

SINDHUJA PUVVADA

Hyderabad

Summary

Dynamic regulatory professional with extensive experience at DXC Technologies, excelling in eCTD submissions and document quality control. Proven ability to ensure compliance with ICH and FDA guidelines while fostering cross-functional collaboration. Skilled in Adobe Acrobat and adept at managing complex regulatory documentation, driving timely submissions and maintaining rigorous compliance standards.

Overview

7
7
years of professional experience

Work History

Analyst III, Business Process Transactions

DXC Technologies
Hyderabad
12.2021 - Current
  • Execute document-level publishing including creation of bookmarks, hyperlinks (internal and external), navigable tables of contents, and fast web view for regulatory submissions
  • Conduct thorough quality checks on submission documents and deliver feedback to team members; ensure documents align with agency requirements
  • Coordinate submissions for IND, NDA, annual reports, and promotional labels (OPDP) in compliance with regulatory timelines
  • Liaise with internal and external stakeholders to ensure timely finalization and submission readiness of regulatory documents
  • Maintain regulatory compliance by following internal SOPs, regulatory templates, and guidelines
  • Support internal audits, maintain submission archives, and track compliance metrics
  • Guide team members on regulatory standards and risk mitigation strategies
  • Process study documentation as per SOPs, work instructions, and ICH guidelines
  • Manage CMC, SLP, and non-CMC (clinical and non-clinical) publishing services, including eCTD modules and IMPD, CTA, NMA, VAR documentation

Management Trainee

Vasudha Pharm Chem Limited
Hyderabad
03.2021 - 12.2021
  • Analyzed and assembled CMC documentation for new DMF preparation, updates, amendments, renewals, and variations as per regulatory requirements
  • Prepared and submitted eCTD documents via Pharma Ready to regulatory authorities
  • Compiled technical and non-technical regulatory documentation, supporting timely submissions
  • Evaluated drug substance specifications and test procedures based on current monographs and regulatory guidelines
  • Reviewed and reported product changes to relevant regulatory agencies
  • Developed and delivered FDA submissions using ESG (Electronic Submission Gateway)

Regulatory Officer

Hetero Labs Limited
Hyderabad
06.2018 - 06.2020
  • Prepared and managed regulatory documents including CEP DOA, US LOA, and ROW market submissions
  • Tracked submissions and maintained accurate records in regulatory databases
  • Compiled amendments and variation documents (process and equipment changes, STP revisions, monograph updates) for global regulatory bodies (USFDA, EDQM, EU, Canada, China)
  • Prepared and submitted Applicant and Restricted Parts for DMFs in eCTD format
  • Drafted Letters of Access and regulatory declarations in line with agency requirements
  • Assessed and processed internal change controls

Education

Master of Science (MSc) - Organic Chemistry

SKSD College
01.2017

Bachelor of Science (BSc) - Life Sciences

Aditya Degree College
01.2015

Skills

  • Regulatory Publishing (eCTD, CMC, SLP, Clinical & Non-Clinical)
  • Document Quality Control & Compliance
  • Adobe Acrobat
  • Prism
  • ISI Toolbox
  • Submission Management (IND, NDA, Annual Reports, DMF)
  • Cross-functional Collaboration
  • Familiarity with ICH, FDA, EU, and global regulatory guidelines
  • Document Archiving & Audit Support
  • ESG (Electronic Submission Gateway) Submissions

Timeline

Analyst III, Business Process Transactions

DXC Technologies
12.2021 - Current

Management Trainee

Vasudha Pharm Chem Limited
03.2021 - 12.2021

Regulatory Officer

Hetero Labs Limited
06.2018 - 06.2020

Master of Science (MSc) - Organic Chemistry

SKSD College

Bachelor of Science (BSc) - Life Sciences

Aditya Degree College

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SINDHUJA PUVVADA