Regulatory Specialist

Zenith LifeScience; Gaithersburg (MD); On-site; USD 25,000 - 33,000; Part time

Job summary

Zenith LifeScience is seeking a motivated undergraduate or master's student to support regulatory intelligence activities for oncology regulatory approval information. You will validate data, analyze regulatory guidance, and present findings using AI-assisted tools.

The role emphasizes collaboration across functions, literature research using public and commercial resources, and developing presentation materials for internal teams in Gaithersburg, MD. US work authorization is required.

Qualifications

• Undergraduate or Masters student majored in Biology, Life Sciences, Pharmaceutical Sciences, Data Science, Engineering or related field.
• US Work Authorization required at time of application.
• Ability to report onsite to Gaithersburg, MD 3-5 days a week.

Responsibilities

• 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 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.

Skills

Data analysis

Presentation skills

Regulatory intelligence

Public speaking

Education

Undergraduate (Biology/Life Sci/Pharma/Data Science)

Masters student

Tools

AI tools

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
• 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.