Rajeshwari Birader Birader

Postgraduate Regulatory Affairs professional with 4 years of experience in regulatory submissions, dossier compilation, product registration, lifecycle management, and regulatory compliance for solid oral dosage forms, ophthalmic solutions, and injectables within the pharmaceutical industry.

Formulation Regulatory Affairs Executive - MSN Laboratories Private Limited - R&D Centre, Hyderabad

(2025-07)

• Preparing, reviewing, and submitting regulatory dossiers (CTD, ACTD, and country-specific formats) for OSD, Injectable, and Ophthalmic products across ROW markets, with extensive experience supporting submissions in LATAM regions, particularl Mexico, as well as the US.
• Analysing regulatory queries received from customers, regional affiliates, and health authorities, and collaborating with cross-functional teams to develop scientifically justified, evidence-based responses.
• Managing product lifecycle activities by preparing and submitting post-approval variations related to quality and manufacturing changes to regulatory authorities.
• Evaluating change controls initiated by cross-functional departments and providing regulatory impact assessments and strategic guidance to ensure regulatory compliance.
• Reviewing and validating packaging artworks and mock ups to maintain continuous compliance with regulatory requirements and approved product information
• Preparing Product Regulatory Information (PRI) documents for approved products, ensuring alignment between approved regulatory information and commercial documentation.
• Reviewing regulatory submissions documents, including process validation reports, pharmaceutical development reports, analytical reports, and stability data.
• Supporting tender participation activities by providing regulatory documentation and compliance-related inputs.
• Authoring scientific justifications, declarations, and regulatory statements to support product registrations, variations, and responses to health authority queries.
• Managing licence activities and CoPP applications (including US, UK, and India), GMP, and Form 25/28.
• Works closely with cross-functional teams as QA, QC, R&D, Clinical and Pharmacovigilance to support in preparing documentation within the development process (e.g. product development reports and Batch records and Stability reports, risk Assessments reports and validation plan/report to ensure regulatory compliances.

Formulation Regulatory Affairs Junior Executive - AMN Life Sciences Private Limited - Mumbai

(2023-12 - 2024-06)

• Submitted CTD dossier for solid oral dosage forms.
• Handled of query submissions with in the time period
• Regular coordination with the cross functional teams for dossier and query required documents
• Handled the sample submissions and maintaining the track details database
• Visted API vendor audits.

Formulation Regulatory Affairs Trainee Executive - Virchow Biotech Private Limited - Hyderabad

(2022-10 - 2023-12)

• Submitted CDSCO SUGAM portal for CT applications
• Submitted CT-10 Application to CDSCO through SUGAM for seeking the NOC to manufacture the new drugs.
• Submitted CT-20 Application to CDSCO through SUGAM for seeking the permission for Marketing Authorization.
• Maintained the SUGAM database which includes applications &Approvals of soft and hard copies.
• Works closely with cross-functional teams as QA, QC, R&D, Clinical and Pharmacovigilance to support in preparing documentation within the development process (e.g. product development reports and Batch records and Stability reports, risk Assessments reports and validation plan/report to ensure the CT Applications and query submission.