Gurugram, Haryana, India
From the chemistry lab to the regulatory desk, my journey has been all about one thing: ensuring the quality and safety of medicines. I began my career in pharma R&D, working on analytical instruments and method development. Today, I’m a Regulatory Affairs professional specializing in CMC for injectables, helping bring compliant, high-quality medications to patients worldwide. Some of my day-to-day activities involve, • Develop and execute regulatory CMC strategies for injectables for the global market. • Preparation, review and submission of Dossier in eCTD format as per country-specific guidelines and requirements for US, EU & Emerging markets. • Coordinate with cross-functional leads to prepare query responses during the review phase of ANDA & EU Applications. • Lifecycle management (variations, renewals) of EU – Application and emerging markets (including new market expansion). • Provide Global CMC evaluations for potential changes at the plant and follow up to ensure regulatory compliance including Change control implementation. • Advise the R&D teams on current regulations and guidances to ensure regulatory data requirements/compliance with new submissions. I know it's a lot 😂 but I love it. Connect with me if you're in the pharmaceutical world, or just love learning about making a difference!🤝 P.S. Always open to chatting about anything from the latest regulations to latest shows to binge watch on OTT.😊
Market: US, EU & ROW Formulation: Simple & Complex Injectables For US: 1. Authoring, review & publishing of Module 1, 2 & 3 for ANDA submissions. 2. Technical Review & timely Submissions of CMC responses to USFDA queries. For EU: 3. Authoring, review & publishing of Module 1 to Module 5 for DCP in Europe. 4. Technical Review & timely submissions of CMC responses to Agency queries. 5. Submissions of Type IA, Type IB and Type II variations for Europe. 6. Evaluation and approvals the regulatory impacted Change Controls and monitoring their implementation in plant to meet compliance requirements. For ROW: 7. Authoring, review & publishing of Module 1 to Module 5 for NDA for ROW countries. 8. Technical Review & timely Submissions of CMC responses to Agency queries. 9. Life cycle management of ROW products through variations/notification packages.