Oncology Regulatory Interns

Descripción del puesto:

We are seeking junior and senior undergraduate or PharmD students majoring in Biology, Life Sciences, Pharmaceutical Sciences, Data Science, Engineering, or a related field for three full time 12-Week Student Intern roles in Gaithersburg, MD for a May 18th - August 7th contract period.

Position Duties:

This posting has three openings for the below teams:

Regulatory Oncology TA Center of Excellence:

* Help with gathering of data for IVDR (in-vitro diagnostics regulation)/GMO (genetically modified organisms) metrics.

* Support an update of GMO regulatory country requirements including research 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 for regulatory intelligence queries using publicly available and commercial tools.

* Research and analyze regulatory guidance, precedence to support our 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 lean principals to 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 and senior undergraduate or PharmD students majoring in a Biology, Life Sciences, Pharmaceutical Sciences, Data Science, Engineering or a 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 regulatory field an added plus.

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

* US Work Authorization is required at time of application.

* This role will not be providing CPT support.

* Ability to report onsite to Gaithersburg, MD 3-5 days a week. This role will not provide relocation assistance.

* Compensation range: $37 - $48 hourly

Date Posted11-Dec-2025

Closing Date08-Jan-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form