Summary
Overview
Work History
Education
Skills
References
Timeline
Generic

Kiran Kataria

Onehunga, Auckland

Summary

Detail-oriented and proactive Regulatory Affairs Specialist with 5 years of experience in the pharmaceutical industry, specializing in product registration, dossier preparation, regulatory submissions, and lifecycle management across local and international markets. Proven track record in interpreting and applying regulatory guidelines (including Medsafe, TGA, FDA, and ICH standards) to ensure full compliance and successful product approvals. Skilled in cross-functional collaboration with R&D, QA, manufacturing, and marketing teams to support both pre- and post-market regulatory activities. Adept at managing multiple submissions, responding to authority queries, and maintaining regulatory databases with precision. Committed to upholding the highest standards of quality, compliance, and ethical responsibility in all regulatory processes.

Overview

5
5
years of professional experience

Work History

Regulatory Affairs Specialist

Alde Medi Impex Limited
, New Delhi
02.2022 - 01.2025
  • Interpreted complex regulatory requirements to ensure compliance with international standards.
  • Coordinated submission of product applications to various regulatory agencies.
  • Conducted investigations of non-compliance issues, identifying root causes and implementing corrective actions.
  • Represented organization in high-stakes meetings with regulatory authorities, advocating for equitable regulation application.
  • Prepared comprehensive documentation and justifications for regulatory decisions, akin to review hearing preparation.
  • Developed clear explanations of technical requirements for non-technical stakeholders, promoting understanding.
  • Managed difficult conversations with clients regarding unfavorable decisions while preserving professional relationships.

Regulatory Affairs Associate

Ananta Medicare Limited
, New Delhi
07.2020 - 02.2022
  • Reviewed and submitted regulatory dossiers for drug applications, variations, renewals, and post-approval changes.
  • Facilitated timely approvals by liaising with health authorities throughout the product lifecycle.
  • Ensured compliance with legal standards by interpreting and applying regulatory guidelines for product materials.
  • Oversaw end-to-end registration processes across multiple markets, including Australia.
  • Created standard operating procedures pertaining to regulatory processes.
  • Monitored industry developments to maintain up-to-date knowledge of compliance requirements.
  • Ensured audit readiness by participating in regulatory inspections and aligning procedures with expectations.
  • Compiled trackers for submission timelines, approvals, and maintained accurate regulatory databases.

Education

Master of Pharmacy - Quality Assurance & Regulatory Affairs

ISF College of Pharmacy
India
07-2020

Bachelor of Pharmacy -

Rajasthan University of Health And Science
India
07-2018

Skills

  • SAP S/4HANA (ERP system)
  • Regulatory compliance and submissions
  • Technical documentation
  • Data analysis
  • Business intelligence tools
  • Performance metrics
  • Quality management
  • Process improvement
  • Effective communication
  • Problem solving
  • Team collaboration
  • Change implementation
  • Risk assessment
  • Stakeholder engagement
  • Audit readiness
  • Client management

References

References available upon request.

Timeline

Regulatory Affairs Specialist

Alde Medi Impex Limited
02.2022 - 01.2025

Regulatory Affairs Associate

Ananta Medicare Limited
07.2020 - 02.2022

Master of Pharmacy - Quality Assurance & Regulatory Affairs

ISF College of Pharmacy

Bachelor of Pharmacy -

Rajasthan University of Health And Science
Kiran Kataria