Summary
Overview
Work History
Education
Skills
Affiliations
Certification
Personal Information
Seminars Workshops Attended
Languages
Dissertation
Timeline
Generic

Nidhi S Rao

Bangalore

Summary

Dynamic, young, and talented pharma-passionate aspirant eager to carve a niche for self in Regulatory Affairs, with experience in managing regulatory submissions, dossier preparation, and market renewals. Skilled in Health Authority queries, document authoring, and data analysis. Strong foundation in pharmaceutical manufacturing, quality control, and supply chain operations.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Regulatory Affairs Officer

IQVIA
Bangalore
03.2025 - Current
  • Reviewed regulatory submissions to ensure compliance with industry standards.
  • Monitored regulatory changes and communicated updates to the team.
  • Collaborated with cross-functional teams to gather necessary documentation.
  • Maintained databases for tracking submission timelines and regulatory requirements.
  • Evaluated changes to documents submitted to determine need for amendments.
  • Assisted in preparing documents for health authority submissions and approvals.

Regulatory Intern

GlaxoSmithKline
Bangalore
09.2023 - 09.2024
  • Coordinated regulatory submissions for MMRV vaccine across diverse markets, ensuring compliance with local and regional regulations.
  • Managed Module 1 operations for market renewals in Serbia, Sri Lanka, Bahrain, and Ghana using Veeva Vault to optimize submission workflows.
  • Collaborated on Health Authority Queries (HAQs), contributing to effective responses and progression of vaccine product submissions.
  • Managed key regulatory documents (e.g., CPPs, GMPs, CoAs) and used PowerBI to analyze data from Health Authority websites for compliance.
  • Contributed to cross-functional harmonization of regulatory deliverables, including translation and adaptation of country-specific documentation.
  • Facilitated team meetings, documenting outcomes and action items to ensure clear communication and project deadlines were met.
  • Drafted Module 1 documents required for critical submissions, working closely with the submission lead to ensure accuracy and alignment with project objectives.
  • Addressed high-priority submission backlogs regionally, as a part of special project by the team lead to resolve outstanding items and successfully clearing 70% issues within a 3-month period.
  • Demonstrated proficiency in Vault platform document management, including expertise in implementing and customizing workflows for efficient document handling.

Industrial Training intern

Micro Labs Pvt. Ltd.
Bangalore
06.2021 - 07.2021
  • Gained hands-on experience in formulation preparation, quality control, and regulatory compliance within manufacturing processes.
  • Explored supply chain operations, focusing on raw material procurement and inventory management to align with regulatory requirements.
  • Developed understanding of QC and microbiological procedures, ensuring adherence to SOPs for microbial safety and batch release criteria.

Education

Masters Program - Pharmaceutical Regulatory Affairs

NITTE Gulabi Shetty Memorial Institution of Pharmaceutical Sciences
Mangalore
01.2024

Bachelor Degree - Pharmaceutical Sciences

Visveswarpura Institute of Pharmaceutical Sciences
Bangalore
01.2021

Senior secondary - PCMB

Jyothi Kendriya Vidyala
Bangalore
01.2017

Skills

  • Microsoft suite
  • Veeva Vault
  • PowerBI
  • Technical Content Writing
  • Document management
  • Regulatory submissions
  • Cross-functional collaboration
  • Effective communication

Affiliations

  • Senior Bharathnatyam dancer (Senior Bharathnatyam exam and Rangapravesha completed)
  • Performed at prestigious functions within India
  • Content writing

Certification

  • Pharmacy Council of India license

Personal Information

Seminars Workshops Attended

  • Regulatory Affairs Workshop, Mr. Srivatsa Rao (General manager, Micro Labs ltd.)
  • Indian Conference on Medical Writing: From basis to recent advances in the field of medical writing, CliMed research solutions
  • "Hand holding the way forward" (2-day webinar), departments of pharmaceutical regulatory affairs, NGSMIPS; Conducted by alumni of NGSMIPS

Languages

  • English
  • Kannada
  • Hindi

Dissertation

Market Specific Requirements for Global Regulatory Submissions, 05/01/24

Timeline

Regulatory Affairs Officer

IQVIA
03.2025 - Current

Regulatory Intern

GlaxoSmithKline
09.2023 - 09.2024

Industrial Training intern

Micro Labs Pvt. Ltd.
06.2021 - 07.2021

Masters Program - Pharmaceutical Regulatory Affairs

NITTE Gulabi Shetty Memorial Institution of Pharmaceutical Sciences

Bachelor Degree - Pharmaceutical Sciences

Visveswarpura Institute of Pharmaceutical Sciences

Senior secondary - PCMB

Jyothi Kendriya Vidyala

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Nidhi S Rao