プロフィール詳細

プロジェクトを作成

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Reema D.に依頼

India

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

プロフィール概要

• 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.

専門分野

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

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Audio Transcription, General Proofreading & Editing, Translation

Research Gap Analysis

Consulting Healthcare Consulting, Regulatory Consulting

Product Development Product Compliance

職務経験

Freelance writer and consultant (self-employed)

Self employed

4月 2025 - 現在

Regulatory CMC Specialist

PLG

10月 2023 - 5月 2025

Manager

Continuum India LLP

7月 2020 - 10月 2023

Manager

RegPak BioPharma Consultant Pvt. Ltd.

9月 2019 - 7月 2020

Sr. Associate- Global Regulatory Services

Apotex Inc.

11月 2011 - 8月 2019

Sr. Executive

Ipca laboratories Limited

8月 2009 - 11月 2011

学歴

MBA

Post Graduate Diploma in Pharmaceutical MBA

6月 2007 - 5月 2009

B.Sc. Biotechnology

Mumbai University

6月 2004 - 4月 2007

認定資格

• Certified Professional in Healthcare Quality

  National Association for Healthcare Quality

  1月 2023 - 現在