Summary
Overview
Work History
Education
Skills
Projects
Publications
Languages
Disclaimer
Timeline
Generic

Kanchanam Ashadeepthi

Kurnool

Summary

Results-driven professional with experience as a Formulation Regulatory Affairs Jr. Officer at Hetero Labs Limited. Expert in e-CTD publications and dossier preparation, ensuring compliance with ICH guidelines. Proven ability to meet critical deadlines through effective communication and cross-functional collaboration, enhancing regulatory efficiency and responsiveness to authority queries.

Overview

1
1
year of professional experience

Work History

Formulation Regulatory Affairs Jr. Officer

Hetero Labs limited
Hyderabad
10.2023 - 10.2024
  • Prepared dossiers for Europe market in compliance with ICH guidelines.
  • Contributed to CMC preapproval submissions for regulatory efficiency.
  • Responded to invalidation queries raised by regulatory authorities effectively.
  • Facilitated duplicate submission processes for MRP and RUPs.
  • Handled CESP submissions to meet critical deadlines.
  • Utilized pharma-ready software for e-CTD publications of MAAs.
  • Checked PDF properties and validated complete dossiers before publication.
  • Sourced product information regularly from EMA, HMA, and MHRA websites.

Education

Master Of Pharmacy - Pharmacology

Sri Padmavati Mahila Visvavidyalayam
Tirupati
09-2023

Bachelor of Pharmacy -

Creative Educational Society College of Pharmacy
Kurnool
08-2021

Skills

  • Microsoft Office proficiency
  • Regulatory compliance
  • e-CTD publications
  • Cross-functional collaboration
  • Effective communication
  • Problem solving
  • Deadline orientation
  • Dossier preparation
  • CMC submissions

Projects

M. Pharmacy: A study on impact of phthalate's exposure on PCOS in the Tirupati region

B. Pharmacy: ADMET prediction and molecular docking of some flavones as cardioprotective agents

Publications

  • Regulatory Authorities and Agencies: Overview in Pharmaceutical Regulatory Science
  • Targeted Drug Delivery: Liposomes, Niosomes, Nanoparticles & Monoclonal Antibodies in Novel drug Delivery system
  • Design, Synthesis, and Antioxidant Evaluation of Gallic Acid-Based Pyrimidine Derivatives
  • In vitro antidiabetic activity of ethanolic extracts of Camellia sinensis L by Using α-Amylase Inhibitory Assay

Languages

Telugu
First Language
English
Advanced (C1)
C1
Hindi
Proficient (C2)
C2

Disclaimer

I hereby declare that all the details furnished above are true to the best of my knowledge.     

Yours Sincerely, AshaDeepthi

Timeline

Formulation Regulatory Affairs Jr. Officer

Hetero Labs limited
10.2023 - 10.2024

Master Of Pharmacy - Pharmacology

Sri Padmavati Mahila Visvavidyalayam

Bachelor of Pharmacy -

Creative Educational Society College of Pharmacy

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Kanchanam Ashadeepthi