Riya Patel

• Led development of an in-house Clinical Trial Planner Platform for EU CTIS and MHRA IRAS, streamlining submission planning, tracking, and oversight within Regulatory Operations. • Developed regulatory strategies for global clinical trial submissions, including EU CTR and China OBRI submissions, ensuring alignment with regional regulatory and operational requirements. • Automated regulatory tracking tools and Excel workflows using VBA/macros to support submission readiness, improving efficiency and data accuracy across Regulatory Operations. • Implemented process improvements that enhanced efficiency in submission management, document control, and regulatory data reporting. • Contributed to the enhancement and maintenance of Regulatory Information Management Systems (RIMS) to ensure data accuracy, compliance, and transparency across global submissions and operational workflows. • Leading requirement gathering, system testing, deployment, and user access management for CTA systems, RIMS, and other Regulatory Operations tools. • Supporting CTA preparation, submission, and tracking — including labeling, indexing, and archival — in compliance with GRA standards, EU CTR, and China OBRI requirements. • Managing regulatory data and metadata within RIMS to improve traceability and enable operational reporting. • Developing and updating SOPs, work instructions, and user guides; monitoring regulatory platforms (Veeva Vault, RIMS, EU CTIS, MHRA IRAS) to ensure data integrity and compliance. • Collaborating with global cross-functional teams and vendors to implement DevOps workflows, enhance submission management systems, and drive process automation within Regulatory Operations (e.g., CREDO). • Regulatory Operations optimization, RIMS and Veeva Vault management, digital process automation, and regulatory data governance. • Cross-functional stakeholder coordination, audit readiness, system validation, and continuous process improvement within Regulatory Operations.

•Assisted in preparation of regulatory submissions for innovative paper-based products, ensuring compliance with Mexico health authority and antimicrobial standards. •Conducted quality and safety assessments of product prototypes, including anti-viral PPE and water filters. •Dossier assembly, document review, and submission support. •Collaborated with RA, QA, and R&D teams to resolve documentation and quality issues. •Evaluated product quality, labeling, and regulatory compliance. •End-to-end regulatory and quality operations. •Submission preparation and health authority compliance. •Product safety and QA monitoring

•Developed a regulatory strategy for Marketing a Class I and Class II medical device in the USA and Asian-Pacific countries (APAC) such as Japan and South Korea along with the medical device registration based on the country-specific regulatory requirements of PMDA and MFDS. •Worked on Preparation of 510K submissions, Technical files using the STED format. Attended meeting with the FDA during the registration process for the class 1 medical device. •Conducted a thorough market analysis on various competitive products and a market analysis to understand the market demand and the current competition for the Class II Medical Device. Collaborated with a third-party organization (MAH) to Prepared Documents for the submission process for the Class 2 medical device for various submissions to the PMDA. •Suggested multiple pathways that ease up the registration process in these countries and also filed a request for designation application to the MFDS and PMDA to assign a classification to the medical device South Korea and Japan.

•Supported preparation of CMC sections, IND modules, and clinical documents (IB, protocols, ICF, CRF) ensuring regulatory compliance. •Assisted in post-market surveillance activities, improving reporting efficiency. •Preparation, review, and maintenance of CTAs, INDs, and safety reporting documents using SharePoint. •Partnering with Clinical, Safety, and Quality teams for material assessments, ensuring GMP/GCP compliance. •Supporting documentation control to maintain regulatory readiness. •Regulatory documentation and submission support. •Compliance with GMP, GCP, and global submission standards. •Cross-functional coordination and post-market surveillance.

Assisted in preparation of submission packages and responses to health authority queries, supporting timely and compliant filings. Conducted safety assessments of raw materials and finished drug formulations (including OTC products). Dossier assembly, document review, and submission support. Collaborating with RA and QA teams to resolve documentation and quality issues. Evaluating product safety data, labeling, and formulation compliance. End-to-end regulatory operations exposure. Submission preparation and health authority query response. Product safety assessment and regulatory compliance.