Summary
Overview
Work History
Education
Skills
Timeline
Generic
Saravakota Sandeep

Saravakota Sandeep

Visakapatnam

Summary

A competent professional with 4+yrs experience in Regulatory Affairs

vertical. Effective communicator with strong team management

coordinating abilities.

Overview

5
5
years of professional experience

Work History

Senior Associate Analyst

Tech Mahindra
Hyderabad
08.2023 - Current
  • Ensuring compliance with regulatory requirements and supporting the successful registration and approval of our products.
  • Collaborate with cross-functional teams to develop regulatory strategies and provide regulatory guidance and expertise throughout the product lifecycle.
  • Maintain accurate and up-to-date regulatory documentation, including technical files, regulatory databases, and correspondence with regulatory authorities.
  • Prepare, review, and submit regulatory filings, ensuring compliance with applicable regulations and guidelines.
  • Understanding of the different regulatory markets, CMC Regulatory Affairs for Pharmaceutical products.

Senior Officer

Lee Pharma Ltd
Visakhapatnam
01.2023 - 07.2023
  • Review of specifications as per the monographs and country specified pharmacopeias to justify the Process development Report.
  • Involve and review every Chemistry manufacturing control change with respect to the DMF and Prepare action plan for annual Revamping.
  • Compilation, Review, updating and maintenance of Drug master file.
  • Coordinate with cross functional teams for Pooling Documents to prepare the DMF's
  • Write-up on list of potential Impurities and control strategy as per specification or Monographs or in line with ICH.
  • Evaluate and establish Control strategies for the Genotoxic Impurities with the help of Sarah and Derek.

Regulatory Affairs Associate

NaturistaNaturista Pharma Pvt Ltd
Visakhapatnam
02.2019 - 12.2022
  • Responsible for maintaining eCTD content consistently with approved manufacturing changes.
  • Review complete CTD dossier from Module one to five according to the standard Master data base and standard protocols.
  • supporting the submission works by tracking of the delivery of activities and fallow-ups.
  • Working with cross functional teams, acquiring knowledge on new products and their
    respective standards.
  • Handling of MONTAJI portal for the Registration of Pharmaceutical Products for DUBAI Municipality.

Education

Master of Science - Regulatory Affairs

Sivani College of Pharmacy
Srikakulamm , SSrikakulam
2019

Bachelor of Science - Pharmacy

Maharajas College of Pharmacy
Vizianagaram
2017

Skills

  • Risk Management
  • Technical Documentation
  • Project Management
  • Document Preparation
  • Database Maintenance

Timeline

Senior Associate Analyst

Tech Mahindra
08.2023 - Current

Senior Officer

Lee Pharma Ltd
01.2023 - 07.2023

Regulatory Affairs Associate

NaturistaNaturista Pharma Pvt Ltd
02.2019 - 12.2022

Master of Science - Regulatory Affairs

Sivani College of Pharmacy

Bachelor of Science - Pharmacy

Maharajas College of Pharmacy

Similar Profiles

CREATE PROFILE
Saravakota Sandeep