Regulatory Affairs Specialist (Remote - US)

Location: Remote within the United States, across multiple states

Company

hirify.global is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission services.

What you will do

• Maintain regulatory submission tracking and archive submissions in document management systems.
• Publish regulatory documents and submissions according to ICH eCTD format, submission-ready standards, and client style guides.
• Prepare and compile documents for submission to regulatory health authorities.
• Perform quality control checks on documents and submissions to verify compliance with ICH, hirify.global, and client standards.
• Coordinate with clinical CROs, local Authorized Agents, and third-party vendors on regulatory submissions.
• Maintain submission project plans, track components, manage risks and timelines, and support multiple projects.

Requirements

• College degree in a scientific, medical, or clinical discipline, or equivalent relevant experience; a master’s degree is preferred.
• At least 3 years of experience in Regulatory Affairs, Regulatory Operations, Publishing, or a similar field.
• Working knowledge of MS Office, Adobe Acrobat Professional, ISI ToolBox, eCTD publishing and viewing tools, SAS Viewer, and WebTrader or ex-US portals.
• Expert knowledge of scientific principles and concepts, with proficiency in MS Word formatting, Adobe, and other MS Office applications.
• Familiarity with 21 CFR Part 11, FDA and GCP requirements, CRO operations, clinical terminology, and the drug development process.
• Strong communication, problem-solving, and collaboration skills.

Nice to have

• Hands-on experience with clinical trials and pharmaceutical development.
• Familiarity with ISO 9001 and ISO 27001 standards.

Culture & Benefits

• Remote full-time position within the United States.
• Supportive, collaborative, and inclusive work environment.
• Opportunity to contribute to clinical research and regulatory operations across pharmaceutical, biotech, and medical device projects.
• Part of a global organization operating across four continents.