Regulatory Business Analyst – GenAI & RIM (Pharma & Medical Devices)

Regulatory Business Analyst – GenAI & RIM (Pharma & Medical Devices) Location: Fort Worth, TX Duration: 6+ Months Required Qualifications • Bachelor's or Master's degree in Life Sciences, Pharmacy, Regulatory Affairs, Computer Science, Information Systems, or related field. • 7+ years of Business Analysis experience within Pharmaceutical, Biotechnology, or Medical Device industries. • Strong experience in Regulatory Affairs and Regulatory Information Management (RIM). • Hands-on experience with Veeva Vault RIM. • Strong understanding of GxP, CSV/CSA, and regulated system environments. • Experience documenting business requirements, process flows, user stories, and acceptance criteria. • Experience working with Agile and Scrum methodologies. • Strong stakeholder management and communication skills. • 2+ years of experience working on Generative AI initiatives, AI-powered business solutions, or intelligent automation programs. • Understanding of Large Language Models (LLMs) and GenAI concepts. • Experience defining GenAI use cases, business requirements, prompt workflows, AI governance requirements, and evaluation criteria. • Exposure to GenAI platforms such as Azure OpenAI, OpenAI, Google Gemini, Anthropic Claude, or similar technologies. • Experience with AI-assisted document processing, summarization, search, content generation, knowledge management, or regulatory intelligence solutions. • Understanding of responsible AI principles, model limitations, hallucination risks, and validation approaches in regulated environments. Thanks and Regards! Lavkesh Dwivedi lavkesh@amtexsystems.com Amtex System Inc. 7 World Trade Center, 46th Fl, Suite 4625 250 Greenwich Street New York, NY 10007 646-200-7139 www.amtexsystems.com