Pranali M Waghmare

With over a decade of experience spanning R&D, production, and regulatory affairs in the pharmaceutical industry, I have developed a comprehensive understanding of drug development, manufacturing, and global compliance. As a Maharashtra FDA-approved technical expert in Bulk Drug and API manufacturing, I have successfully led and navigated high-stakes regulatory audits, including MHRA, USFDA, WHO, and various vendor inspections, demonstrating a strong foundation in technical operations, quality compliance, and regulatory strategy. My journey began in pharmaceutical R&D, where I contributed to the formulation and optimization of soft gelatin pediatric calcium capsules, a role that provided me with in-depth knowledge of formulation sciences and process development. During this time, I also pursued my Master’s degree in Pharmacy with a specialization in Pharmaceutics, laying a strong academic foundation in pharmaceutical sciences. Transitioning into API manufacturing, I earned technical approval from Maharashtra FDA, allowing me to lead key regulatory audits and maintain compliance with stringent global standards. Further enhancing my regulatory expertise, I completed a Postgraduate Diploma in Drug Regulatory Affairs, equipping me with a deep understanding of product lifecycle management, regulatory submissions, and global compliance strategies. Over the years, I have played a pivotal role in global regulatory submissions across major markets, including the EU, US, APAC, LATAM, the Middle East, and Africa, ensuring streamlined approvals and market access for both pharmaceutical and vaccine products. My current role involves coordinating regulatory submissions while serving as a subject matter expert for product activation and reactivation, ensuring the efficient availability of medicines across global markets. Passionate about regulatory process optimization, digital transformation, and AI-driven compliance solutions, I focus on leveraging automation, data analytics, and strategic regulatory planning to accelerate approvals, optimize regulatory pathways, and enhance operational efficiencies. My commitment extends beyond compliance; I aim to integrate scientific innovation, regulatory intelligence, and digital tools to ensure timely access to high-quality medicines, ultimately improving patient safety and global healthcare access. Recognizing the evolving landscape of regulatory affairs, I am further advancing my expertise by pursuing a Certificate Program in Project Management from IIM Indore and a Certificate Program in Generative AI for Managers from TimesPro Institute, equipping myself with advanced project management skills and AI-driven regulatory strategies. These programs are enhancing my ability to drive digital transformation within regulatory frameworks, streamline submission processes, and introduce innovative compliance solutions that align with global regulatory expectations. With a strong background in scientific knowledge, regulatory strategy, and compliance excellence, I am dedicated to shaping a more agile, efficient, and patient-centric regulatory environment that ensures the timely delivery of safe, effective, and high-quality healthcare products to global markets. Through my expertise, I seek to bridge the gap between regulatory requirements and industry innovation, reinforcing regulatory affairs as a strategic enabler of global healthcare advancements. Regulatory professional with comprehensive experience in compliance management and regulatory affairs. Adept at navigating legal frameworks, ensuring adherence to industry standards, and mitigating risk. Proven track record in collaborating with cross-functional teams and delivering measurable results. Strong analytical skills, adaptability, and consistent focus on achieving organizational objectives.

Certificate programme in Project Management (CPPM) from Indian institute of Management (IIM), Indore