Regulatory Affairs Informatics Specialist at Catalytic Data Science Full Time

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.