Oncology Regulatory Interns

We are seekingjunior and seniorundergraduate or PharmD students majoring in Biology, Life Sciences, Pharmaceutical Sciences, Data Science,Engineering,or a related field for threefull time12-Week Student Intern roles in Gaithersburg, MD for a May 18th - August 7th contract period.

Position Duties:

This posting has three openings for thebelowteams:

Regulatory Oncology TA Center of Excellence:

• Help withgathering ofdata for IVDR (in-vitro diagnostics regulation)/GMO (genetically modified organisms) metrics.

• Support an update of GMO regulatory country requirements includingresearch of publicly available information.

• Support EUDAMED(European database on Medical Devices)implementation.

• Support SDTL (submission delivery team leads) Academy AI agent creation.

Oncology Regulatory Intelligence:

• 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 forregulatoryintelligence queries using publicly available and commercial tools.

• Research and analyze regulatory guidance, precedenceto supportour products and development pipeline

CMC RA Devices and Digital Therapeutics Team:

• Assess and improve select existing regulatory processes for medical devices and combination products.

• Apply leanprincipalsto understand current process needs, address stakeholder input, implement changes, and propose effectiveness checks.

• Re-brand and launch agreed process improvements.

• Relevant examples of regulatory processes may include medical device software classification assessment, medical device registration and listing, and unique device identification.

Position Requirements:

• Junior andsenior undergraduate or PharmD students majoring ina Biology, Life Sciences, Pharmaceutical Sciences, Data Science,Engineeringora related field.

• Candidates must have an expected graduation date after August 2026.

• Background knowledge of lean principles, user-centered design, and process development preferred.

• Medical device knowledge and interest preferred.

• Experience with data analysis, presentation skills, and ability to search in external sources required. 

• Experience or interest in digital/AI/automation and the regulatoryfieldan added plus.

• Enthusiasm for collaboration, cross-functional projects, public speaking, and presentation design.

• US Work Authorization isrequiredattimeof application.

• This role will notbe providingCPT support.

• Ability to report onsite to Gaithersburg, MD3-5days a week. This role will not provide relocationassistance.

• Compensation range: $37 - $48 hourly