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.