Regulatory Affairs Informatics Specialist
2 months ago
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.
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