Job Title: Regulatory Affairs Informatics Specialist Location: Remote (Quarterly In-Person Team Meetings) Company: Catalytic Data Science About Us: Catalytic Data Science is a start-up revolutionizing the life sciences industry with cutting-edge AI platforms designed to enhance Regulatory Affairs Intelligence. Our talented and hardworking team spans engineering, data science, product development, and regulatory intelligence. We are building a new type of regulatory intelligence platform using AI-driven workflows that enable Regulatory Affairs teams to work faster and more accurately when developing new clinical trial and regulatory filing strategies. Position Overview: We are seeking a skilled Regulatory Affairs Informatics Specialist to join our dynamic team. Reporting to the Head of Product, this role will be pivotal in developing AI-driven workflows that enhance the efficiency and accuracy of Regulatory Affairs teams. The ideal candidate will have experience in pharmaceutical or biotechnology regulatory intelligence or a related role. Key Responsibilities: Meet with life sciences customers to understand current workflow challenges Work with Catalytic’s Product Team to identify solutions and create product roadmaps Use your domain expertise to assist Catalytic’s QA team in creating data accuracy tests Use your domain expertise to create ground truth data sets to benchmark model performance Participate and present ideas at weekly Product meetings Travel to industry conferences to meet with potential customers and identify new product opportunities Required Qualifications: Master’s degree in Regulatory Science, PharmD, or a related discipline Minimum of 5 years of experience in a regulatory intelligence role or related field within a biotechnology or pharmaceutical company Proficiency in primary research techniques essential for building regulatory strategies In-depth knowledge of regulatory documentation required by health authorities throughout the clinical development process Strong verbal and written communication skills Critical thinker with the ability to solve problems independently Additional Beneficial Qualifications: Formal project management training. Experience with ex-US health authorities, particularly the EMA, Japan, and China. Basic understanding of Large Language Models (LLMs) and their potential use cases in Regulatory Affairs. Benefits: Competitive salary Stock options Medical, dental, and vision coverage Flexible self-managed time off policy Join Catalytic Data Science and contribute to the future of Regulatory Affairs Intelligence in the life sciences industry. Together, we can make a difference. Catalytic Data Science is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.