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Hire Reema D.

India

USD 50 /hr

15 years of experience in CMC author, Post-Approval Changes, Query Respons, XEVMPD, labelling , Safety Variation

Profile Summary

• Preparation of CTD sections of the dossiers required for Regulatory submission in various countries namely EU (National, MRP and DCP), US (ANDA- Prescription and Consumer), Canada (ANDS) and Australia (Prescription Medicines). • Compilation of deficiency-response and submission to health authorities. • Categorization of post-approval changes and accordingly preparation of change packages including CMC/administrative changes, safety or labelling changes, renewals, MA transfers, Withdrawals. Handled type-IAIN, type IA, type IB, type II changes of EU and CBE-0, CBE-30, PAS for US markets. • QC review or gap analysis of dossier, query-responses and post-approval variation packages. • Booking of slot, interacting with health agency, fees calculation, Registration in SPOR, • Creation and maintenance of product information in XEVMPD/ Eudravigilance environment using web-trader. • Sharing the updates/status with the clients via email notifications. • Regulatory dossier due diligence. • Software Skills- MS Office, Adobe Professional, Tru, global change control, Dossplorer, CEDMS, RIMS, Trackwise, Docubridge, Citrix, Educe.

Subject Matter Expertise

• ☆ Pharmacy
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Regulatory Writing
• ☆ CMC Documentation

Services

• Writing
• Research
• Consulting
• Product Development

Writing Audio Transcription, General Proofreading & Editing, Translation

Research Gap Analysis

Consulting Healthcare Consulting, Regulatory Consulting

Product Development Product Compliance

Work Experience

Freelance writer and consultant (self-employed)

Self employed

April 2025 - Present

Regulatory CMC Specialist

PLG

October 2023 - May 2025

Manager

Continuum India LLP

July 2020 - October 2023

Manager

RegPak BioPharma Consultant Pvt. Ltd.

September 2019 - July 2020

Sr. Associate- Global Regulatory Services

Apotex Inc.

November 2011 - August 2019

Sr. Executive

Ipca laboratories Limited

August 2009 - November 2011

Education

MBA

Post Graduate Diploma in Pharmaceutical MBA

June 2007 - May 2009

B.Sc. Biotechnology

Mumbai University

June 2004 - April 2007

Certifications

• Certified Professional in Healthcare Quality

  National Association for Healthcare Quality

  January 2023 - Present