Regulatory Drug Project Specialist

Regulatory Drug Project Specialist

Location: Gaithersburg, MD

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 3 months
• Pay Rate: $36.00 / Hour (USD)
• Shift / Schedule: Days (First Shift), flexible hours (9 5 or 8 4)
• Travel Requirements: This role will not provide relocation assistance.
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

This is a 3 4 month contract assignment supporting regulatory intelligence and data validation activities within a global biopharmaceutical organization's oncology regulatory team, based at the Rio location in Gaithersburg, MD. The role was originally scoped for a summer intern but is open to candidates with a basic science degree and minimal post-graduate experience. Titles such as "research associate" are likely a good fit for this position; it is not necessary for the candidate to hold the exact title of "specialist regulatory drug project." The role requires reporting onsite three days a week, with flexible hours (9 5 or 8 4).

Key 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 precedence to support our products and development pipeline

Required Skills

• Experience with data analysis, presentation skills, and ability to search external sources
• Strong analytical skills and comfort working with scientific data (as seen in scientific publications, not computer/data engineering)
• Strong communication skills; candidate must be transparent, open, accountable, and responsible able to take direction and execute
• Ability to report onsite to Gaithersburg (Rio location), MD three days a week
• US Work Authorization required at the time of application

Preferred Skills

• Experience or interest in digital/AI/automation and the regulatory field
• Enthusiasm for collaboration, cross-functional projects, public speaking, and presentation design

Education Requirements

• Junior and senior undergraduate or master's student majoring in Biology, Life Sciences, Pharmaceutical Sciences, Data Science, Engineering, or a related field
• Preferred educational background: Bachelor's in health or biological sciences (biochemistry, clinical research, regulatory affairs, etc.); a master's is also acceptable

Required Experience

• Minimum experience outside of school is acceptable since the original intention was for a soon-to-graduate intern; about a year of experience is sufficient

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Important Notes

• Interview process: 2 rounds (1) 30-minute video with the hiring manager only; (2) 30-minute video with the hiring manager and line manager, including a 10-minute presentation by the candidate. Details will be sent via email if the candidate advances to the second round.

About the Client

This global biopharmaceutical company is driven by a single, defining mission to push the boundaries of science and deliver life-changing medicines that transform the lives of patients worldwide. With a global footprint spanning more than 100 countries, the organization focuses on three core therapy areas: oncology, cardiovascular and metabolic disease, and respiratory and immunology, while also advancing treatments in rare diseases and vaccines. Employing tens of thousands of scientists, clinicians, and business professionals globally, this organization combines the resource depth of a top-tier pharma company with a genuine culture of scientific curiosity. Research programs span small molecules, biologics, cell therapy, and RNA technologies, giving employees exposure to the full frontier of modern drug development. In 2026, employees voted this organization onto Glassdoor's Best Places to Work list, and it holds an overall Glassdoor rating of 4.0 stars from nearly 8,000 reviews. Teams here span oncology researchers, clinical trial specialists, regulatory scientists, and commercial and market access professionals.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-10524 Industry: Manufacturing & Operations

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