Jobs

Location: Rio location in Gaithersburg MD

Position Title: Regulatory Specialist or Regulatory Associate

Duration: 3-4 months

The role is intended for a 3-4 month assignment, originally scoped for a summer intern, but open to someone with a basic science degree and minimal post-grad experience.

• Preferred educational background: bachelor’s in health or biological sciences (biochemistry, clinical research, regulatory affairs, etc.); a master's is also acceptable.
• Candidate should have strong analytical skills and be comfortable working with scientific data (not computer/data engineering, but scientific data as seen in publications).
• Communication is key: candidate must be a good communicator, transparent, open, accountable, and responsible—not necessarily strong in presentations, but able to take direction and execute.
• Titles such as "research associate" are likely a good fit for this position; it's not necessary for the candidate to hold the exact title of "specialist regulatory drug project."
• required on-site three days a week, with flexible hours (9-5, or 8-4).
• 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.  

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

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.

Position duties:

• 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.