Monika Jain

About Monika Jain

Healthcare Industry Leader and Subject Matter Expert with 20+ Years\' Experience in…

Experience

1. Senior Manager - Regulatory Affairs and Process Remediation

   ClinChoice

   Mar 2015 — Present · Bangalore, IN

   ClinChoice is a global clinical CRO. I manage 2 global projects for a major US Pharma-Consumer giantProcess Remediation Drug Listing: North America Region: Helped US regulatory product information and data strategy and digitalization efforts Successfully revamped Drug Listing process by implementing direct listing to FDA through CDER Direct portal. Eliminated the need for a third-party vendor, reduced TAT from 7 to 2 days Developed and executed data reporting regulatory requirements under FDA Cares Act for Consumer and Self care products by massaging, collating, organizing large amounts of product data. Identified gaps in internal data from multiple in-silo business tools, leading to a new, simplified process and valuable insights for leadership Successfully validated and updated 1532 actively marketed drug product records in Regulatory Information Management System by identifying products withdrawn from market and duplicate records. Harmonised FDA Drug listing data by standardizing process data updation for new and existing records, resulting in accurate product data management system. Mapped current regulatory global procedures like Global change Control, DHCP Letters, USRs Management, Health Authority Queries and Post Marketing Commitments. Analyzed the current global procedures on these for compliance to applicable regulatory requirements, company policies and procedures. Lead management and reporting of Global Health Authorities Queries by coordinating with Globalrecord owners and Qualified Person Pharmaco-Vigilance for compliance with SOPs and regulations.Authorization for Product Release (APR) Review – US Region: Ensured technical regulatory, quality and safety compliance for over 200 cosmetic products for submission to FDA’s Voluntary Cosmetic Registration Program. Coordinated with R&D, Quality, Toxicology, Safety, Regulatory, Technology transfer departments for timely review of APRs, to support successful product launches in US Market.

Skills

• Biotechnology
• Clinical Trials
• Regulatory Affairs
• Lifesciences
• Immunology
• Clinical Development
• Validation
• Life Sciences
• Clinical Research
• Pharmaceutical Industry
• Sop
• Fda
• Drug Discovery
• Pharmacovigilance
• Oncology
• Gmp
• CRO
• Gcp
• Microbiology