What are the responsibilities and job description for the Regulatory Affairs Informatics Specialist position at Catalytic Data Science?
Job Title: Regulatory Affairs Informatics Specialist
Location: Remote (Quarterly In-Person Team Meetings)
Company: Catalytic Data Science
About Us:
Catalytic Data Science is transforming Regulatory Affairs in the life sciences industry with advanced AI platforms that elevate regulatory intelligence, strategy, and precedent analysis. Our dedicated team—spanning engineering, data science, product development, customer success, and regulatory science—works relentlessly to develop AI-powered workflows that help regulatory professionals operate with greater speed and precision while remaining compliant with health authority guidelines.
Position Overview:
We are looking for an experienced Regulatory Affairs expert to join our dynamic team. Reporting to the Head of Product, this role will play a key part in developing AI-powered workflows that improve the efficiency and accuracy of Regulatory Affairs teams. The ideal candidate has a background in pharmaceutical or biotechnology regulatory intelligence, strategy development, or a related field.
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 affairs role or related field within a biotechnology or pharmaceutical company
- Proficiency in primary research techniques essential for building regulatory intelligence reports and regulatory strategies
- In-depth knowledge of regulatory documentation required by health authorities throughout the clinical development and approval 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.