Bansri Shah

-Contributed in defining the regulatory strategy for innovative Virtual Reality (VR) Medical device. -Conducted a through analysis to address critical regulatory questions, including identifying potential predicate devices, determining FDA device classification & submission type & evaluating pros and cons of all applicable regulatory pathways like De Novo, 510(K) exempt, 510(K), Pre-submissions. -Established an actionable regulatory roadmap for the company , ensuring alignment with FDA standards and guiding the strategic approach for market introduction.

• Ensure continuous adherence to current Good Manufacturing Practices (cGMP), FDA regulations, MoCRA, and CFR 21 Part 210 and Part 211 through ongoing study and participation in relevant training programs. • Review and interpret regulatory guidelines and communicate regulatory requirements to internal stakeholders. • Assess formulations for compliance with EU regulations, Health Canada standards, and California Proposition 65 requirements. • Oversee all regulatory requirements to support customer needs and ensure comprehensive product compliance. • Collaborate with raw material suppliers, purchasing, and R&D teams to guarantee raw materials meet customer specifications. • Review product labels to enhance consumer appeal, meet customer specifications and ensure regulatory compliance for product approval. • Qualify and maintain high compliance standards for raw material suppliers. • Coordinated with the quality, R&D, regulatory unit, promoting a culture of compliance and excellence. • Prepare and review qualitative and quantitative ingredient lists for regulatory compliance as per EU & USA. • Conduct facility audits to ensure compliance and manage pest control programs. • Continuously kept an eye on EU and FDA website for updated regulation regarding personal care products to enhance regulatory compliance and operational efficiency.

• Prepared and reviewed financial forecasts and budgets for regulatory projects, ensuring resource allocation aligns with strategic planning and regulatory requirements. • Led and managed cross-functional teams of almost 50 people, including regulatory specialists, to design, develop, and launch regulatory submissions within established timelines, ensuring compliance with FDA regulations and guidelines. • Developed a comprehensive regulatory roadmap for 14 products using Primavera, outlining the regulatory submission process, milestones, and responsibilities to ensure seamless coordination and adherence to regulatory requirements. • Conducted thorough analyses of potential drugs (20 products each quarter) and their regulatory implications, providing valuable insights to the regulatory affairs team and stakeholders, aiding in strategic decision-making.

Responsible for guiding all the sports team leader's decision Responsible for making the event successful within the given timeline Responsible for communicating the itinerary to higher-level management

• Demonstrated ethical and compliant practices while engaging with healthcare professionals to promote rabeprazole, resulting in 40% increased prescriptions for the drug. • Expertly conveyed accurate product information, maintained detailed records of interactions, and participated in ongoing training to stay updated with industry regulations and medical developments.

Performed as Quality Assurance executive Understood all the aspects of the quality approval process of the drug. Understood the SOP making procedures and standards to pass all the qualitative tests. Qualitative aspects of the safety and efficacy of the drug.