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
Date Posted
11-Dec-2025Closing Date
08-Jan-2026Our 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.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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