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

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)

Hindi

Proficient (C2)

Disclaimer

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

Yours Sincerely, AshaDeepthi

Timeline