Riya Patel
Regulatory Technology Specialist @Otsuka Pharmaceutical Companies (U.S.)
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WORK HISTORY
Regulatory Technology Specialist @Otsuka Pharmaceutical Companies (U.S.)
Princeton, NJ, US
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.
EDUCATION
Northeastern University
Master's degree, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
Charotar University of Science & Technology (CHARUSAT)
Bachelor of Pharmacy - BPharm, Pharmacy
ABOUT RIYA PATEL
Regulatory affairs associate business Analyst with 6+ years of experience in global clinical trial submissions, regulatory operations, and digital transformation initiatives. Led the development of an in-house Clinical Trial Planner Platform for EU CTIS and MHRA IRAS, enhancing submission planning, tracking, and visibility. Skilled in translating regulatory and business requirements into technical solutions, automating workflows using VBA and macros to improve data accuracy and operational efficiency. Experienced in collaborating with cross-functional teams and vendors to implement and optimize regulatory systems, ensuring compliance with GRA, EMA, MHRA, FDA, PMDA, and MFDS standards. Adept at process improvement, system enhancement, and driving data driven decision-making within Regulatory Business Analysis & Global Submission Management (EU CTIS, MHRA IRAS)Graduated from Northeastern University with a Master’s degree in Pharmacy Administration and Regulatory Affairs, bringing expertise in global regulatory processes and submissions, ICH guidelines, and eCTD documentation. Academic foundation includes a Bachelor’s degree in Pharmacy from Charotar University of Science & Technology.
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