Summary
Overview
Work History
Education
Skills
Languages
Websites
Timeline
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Sushma kasirala

Tirupati

Summary

Accomplished Regulatory Affairs professional with 7.6 years of experience, including 5+ years in post-approval submissions and CMC dossier compilation (EU). Skilled in developing and executing regulatory strategies to secure and maintain product approvals across international markets. Strong expertise in EMA/ICH regulations, lifecycle management, and cross-functional collaboration with proven success in responding to Health Authority queries and supporting global regulatory strategies.

Overview

8
8
years of professional experience

Work History

Research Associate - II

Alphamed Formulations Pvt Ltd
Hyderabad
03.2021 - Current
  • Handled post-approval submission processes and lifecycle management activities for EU and global markets.
  • Evaluated CMC dossiers and identified deficiencies, ensuring compliance with EMA/ICH requirements.
  • Compiled registration dossiers (CTD format), meeting agency timelines.
  • Contributed to international regulatory strategy for submissions and variations.
  • Collaborated with cross-functional teams including the Global Regulatory Team (GRT).
  • Compiled responses for Health Authority queries using knowledge management systems.
  • Maintained product lifecycle data in Veeva Vault RIM, TrackWise, QAlign, and SharePoint.
  • Participated in cross-functional meetings for strategic planning and regulatory risk management.

Junior Regulatory Affairs Officer

Hetero Labs Ltd
Hyderabad
05.2019 - 03.2021
  • Prepared CMC pre-approval submissions in line with EU/ICH guidelines.
  • Supported Marketing Authorization Applications (MAA).
  • Compiled and submitted DCP/MRP dossiers for European markets.
  • Created e-CTD publications using Pharma Ready (initial MAA and follow-up responses).
  • Ensured compliance with centralized and decentralized procedures.
  • Provided support in regulatory strategy discussions and cross-functional coordination.

Regulatory Junior Executive

Lactonova Nutripharm Pvt Ltd
Hyderabad
11.2017 - 04.2019
  • Prepared regulatory dossiers in compliance with FSSAI and regional requirements.
  • Reviewed product labels, cartons, inserts, and literature for compliance with label guidelines.
  • Maintained product registrations and submissions with regulatory authorities.
  • Coordinated product licenses, manufacturing approvals, and trademark applications.

Education

Master of Science - Regulatory Affairs

Jawaharlal Nehru Technological University
Tirupati
03-2020

Bachelor of Science - Pharmacy

Jawaharlal Nehru Technological University Anantapu
Tirupati
06-2017

Skills

  • Regulatory submissions (MAA, lifecycle management)
  • EMA/ICH regulations & CTD format
  • Post-approval variations & strategies
  • Regulatory queries & Health Authority interactions
  • Veeva Vault RIM, TrackWise, QAlign, SharePoint
  • Pharma Ready, Lorenz Validator
  • Expedited pathways and reliance mechanisms
  • Knowledge management & regulatory intelligence
  • Cross-functional collaboration & global regulatory strategy development

Languages

Telugu
First Language
English
Proficient (C2)
C2
Hindi
Intermediate (B1)
B1

Timeline

Research Associate - II

Alphamed Formulations Pvt Ltd
03.2021 - Current

Junior Regulatory Affairs Officer

Hetero Labs Ltd
05.2019 - 03.2021

Regulatory Junior Executive

Lactonova Nutripharm Pvt Ltd
11.2017 - 04.2019

Master of Science - Regulatory Affairs

Jawaharlal Nehru Technological University

Bachelor of Science - Pharmacy

Jawaharlal Nehru Technological University Anantapu

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Sushma kasirala