Regulatory Specialist

Job Description:

• Support data validation activities in our digital tool for oncology regulatory approval information.
• Help with presentation of regulatory intelligence data analyses using AI tools.
• Undertake background literature research for regulatory intelligence queries using publicly available and commercial tools.
• Research and analyze regulatory guidance, precedence to support our products and development pipeline

Position duties :

• Support data validation activities in our digital tool for oncology regulatory approval information.
• Help with presentation of regulatory intelligence data analyses using AI tools.
• Undertake background literature research for regulatory intelligence queries using publicly available and commercial tools.
• Research and analyze regulatory guidance, precedence to support our products and development pipeline
• Experience with data analysis, presentation skills, and ability to search in external sources required.
• Experience or interest in digital/AI/automation and the regulatory field an added plus.
• Enthusiasm for collaboration, cross-functional projects, public speaking, and presentation design.

Position Requirements :

• Junior and senior undergraduate or Masters student majored in a Biology, Life Sciences, Pharmaceutical Sciences, Data Science, Engineering or a related field.
• US Work Authorization is required at time of application.
• Ability to report onsite to Gaithersburg, (Rio location) MD 3-5 days a week. This role will not provide relocation assistance.