Summary
Overview
Work History
Education
Skills
Certification
Projects
Timeline
Generic

Deebika A

Chennai

Summary

Skilled regulatory affairs professional with experience in regulatory submissions and laboratory practices. Focused on ensuring compliance, streamlining processes, and fostering communication between internal teams and regulatory authorities to support product approval and commercialization.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Regulatory affairs Executive

Apex Laboratories Pvt Ltd
Chennai
11.2024 - Current
  • Assisted in the preparation of CTD Modules 1 and 2 for semi-regulated markets
  • Gained exposure to CMC document structures and learned ICH Q-series requirements.
  • Collaborate with cross-functional teams to develop and review product labels for compliance with regulatory guidelines.
  • Manage labeling updates in response to new regulations, product changes, or safety data.
  • Coordinate artwork development with design teams and vendors for packaging.
  • Collaborated with the labeling team to update product information, nutritional facts, and other label details in line with FSSAI requirements.

Regulatory affairs Executive

Axxelent Pharma Science Private Limited
Chennai
04.2022 - 11.2022
  • Review and authorization of all technical documents such as API/Finished Product/ Excipients
  • Responsible for review of RLD package insert for generic drug development
  • Handling Licensing activities such as NOC, Test License, Import License for generic products and responsible for submission of responses to queries
  • Managed license applications, renewals, and amendments for pharmaceutical products, ensuring timely compliance with regulatory authorities.
  • Coordinate activities among team members to meet project milestones and deadlines

Bench chemist

Central Drugs Testing Laboratory
Chennai
07.2019 - 03.2022
  • Quantitative and Qualitative estimation on pharmaceutical finished products, active pharmaceutical ingredients and cosmetics
  • Instruments handled such as UV visible spectrometer, FTIR, High performance liquid chromatography, dissolution apparatus, disintegration test apparatus, and digital polarimeter
  • Record experimental data meticulously and maintain accurate laboratory notebooks
  • Manage laboratory supplies, chemicals, ensuring adequate inventory levels and proper storage
  • Conducted routine calibration and maintenance of laboratory instruments to ensure accuracy and reliability.

Education

M. Pharmacy -

Madurai Medical College
Madurai
05.2019

B. Pharmacy -

Madras Medical College
Chennai
08.2016

High school -

Lady M. Ct. M girls Hr. Sec. School
Chennai
03.2012

Skills

  • CTD/eCTD Structure & Requirements
  • CMC Documentation (Module 3)- Theoretical Knowledge
  • Document Management Systems (DMS)- Concepts
  • Documentation review
  • Regulatory Compliance
  • Cross-Functional Team collaboration
  • Communication skills
  • Microsoft Word
  • Adobe Acrobat
  • Excel Trackers

Certification

  • Pharma Drug regulatory affairs certificate course- Udemy
  • ECTD & CTD Preparation and Submission Course- Udemy
  • Typewriting- Higher in English, Tamil
  • Diploma in office automation
  • Diploma in desktop publishing

Projects

B. Pharmacy, Synthesis and characterization of antimicrobial activity of some indole derivatives.

M. Pharmacy, Pharmacognostical, phytochemical studies and evaluation of anti-thyroid activity on leaves of Cichorium intybus L. (Asteraceae).

Timeline

Regulatory affairs Executive

Apex Laboratories Pvt Ltd
11.2024 - Current

Regulatory affairs Executive

Axxelent Pharma Science Private Limited
04.2022 - 11.2022

Bench chemist

Central Drugs Testing Laboratory
07.2019 - 03.2022

M. Pharmacy -

Madurai Medical College

B. Pharmacy -

Madras Medical College

High school -

Lady M. Ct. M girls Hr. Sec. School

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Deebika A