Pooja Pharate

Background

About Pooja Pharate

Greetings! I'm Pooja Pharate, a dynamic Regulatory Affairs Professional, specialize in guiding products seamlessly from development through approval in highly regulated markets. My expertise lies in interpreting and applying regulatory guidelines to ensure compliance, mitigate risk and streamline processes prioritizing patient safety and product efficacy. Education: A proud holder of Master’s in Pharmacy with specialization in Drug Regulatory Affairs, equipping me with a comprehensive understanding of pharmaceutical industry's regulatory landscape. Academic training provided me with in depth knowledge of drug development, quality assurance and compliance with global regulatory standards. Professional Expertise: I thrive in dynamic environments where accuracy and strategic planning are essential. As a passionate working professional in Life Cycle Management, I bring a comprehensive skill set focused on managing product variations, re-registrations, addressing queries (critical & technical) and change control.(For countries: Anglo Africa, CIS, WA, SEA) Gratefully having opportunity of company/site registrations in various regions. Coordinating with own manufacturing plants/TP/LL sites to meet the country specific requirement, legalization of documents from COO and reference countries, compiling & submitting documents required for GMP inspection [for medicinal product (General & Hormonal Category, Beta lactams, Parenteral, SVP), Dietary supplements, Cosmetics & Herbal products manufacturing site], managing CAPA submissions to address any identified issues or potential risks, ensuring continuous improvement in compliance and operational processes. Experienced countries- 1. Via LTR for- Iraq (MOH & KMCA), Uzbek, Kyrgyz (according to EAEU), Yemen, Kenya, Uganda, Shree Lanka, Zimbabwe, Ghana, Nigeria. Site registration though portal, having hands on ZAMRA-Zambia, TMDA- Tanzania & RFDA- Rwanda. Via centralized procedure thorough EAC (East African Community)for EAC member state. Site registration along with product registration (For Jordan, Kazakh, GCC members) Additionally, my role involves submitting PSURs in compliance with EMA guidelines, which summarize safety profile of product post-launch. Hands on updating PSUR calendar, submission of Benefit risk analysis, PSUR, RMP, ADR report & PSMF in Kazakh, Uzbek & Kyrgyz. Passion: Beyond professional sphere, i am an avid traveler, finding joy in exploring new places. I also enjoy immersing myself in books, spiritual events and broadening my horizon & knowledge.