A highly skilled professional with expertise in writing and oral communication, project management, and analytical reasoning. Demonstrates proficiency in equipment handling and presentation skills, contributing to effective project execution and stakeholder engagement. Committed to leveraging these competencies to drive organisational success and pursue opportunities for growth within dynamic environments.
Overview
3
3
years of professional experience
Work history
Regulatory Executive
Balaxi Pharmaceuticals Limited
Hyderabad
02.2022 - 11.2022
Compilation, review and filling of CMG for LATIN AMERICA and AFRICAN Countries.
Authoring of responses with suitable justification for HA queries.
Collaborated with global colleagues and involved in Health Authority interactions.
Diligently collaborated with the respective associates in meeting the key milestones and timelines.
Answering queries, review and submission of Dossiers for medicinal products in CTD, CIS and Latin American countries.
Active Co-ordination with F&D, Production, Quality Control, Quality Assurance, Packaging and IBD departments while identifying discrepancies in technical data.
Strictly adhered in reviewing and authoring the documents like Standard testing procedures, Batch manufacturing records, specifications, validations, In-Process specifications, Process development reports, stability protocols & Art works.
Maintained rapport with the management and team by periodic meetings.
Intern
NATCO Pharma
02.2020 - 04.2020
Internship in Formulations and research department.