Regulatory Specialist

Job not on LinkedIn

🕒 September 25

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🚔 Compliance

🚫👨‍🎓 No degree required

👻 Ghost score 29%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Prolerity Clinical Research

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

☁️ SaaS

Healthcare • Biotechnology • SaaS

Prolerity Clinical Research is a U. S. -based clinical research site network that operates research clinics across multiple states (Louisiana, Florida, New Jersey, New York). The company conducts phase I–IV clinical trials across a wide range of therapeutic areas including liver disorders (MASH/MASLD), cardiometabolic, CNS, vaccines, ENT, respiratory, dermatology, migraines, gastroenterology, acute/chronic/neuropathic pain, neurology, cognition/dementia, and general medicine. Prolerity focuses on patient recruitment, high-quality data collection, patient care, and serving diverse communities. It positions itself as a partner for pharmaceutical and biotech sponsors needing efficient site networks capable of rapid recruitment and study start-up.

📋 Description

• Prepare and submit regulatory documents to IRBs, sponsors, and internal stakeholders, including initial submissions, amendments, continuing reviews, and safety reports • Maintain and update Investigator Site Files, regulatory binders, and electronic systems such as CRIO, Veeva, and Complion • Coordinate collection and submission of study start-up documents, including site questionnaires, training logs, CVs, and delegation logs • Ensure documentation complies with ICH-GCP, FDA regulations, and sponsor-specific requirements • Liaise with research staff, investigators, sponsors, and IRBs to facilitate regulatory processes • Keep regulatory files audit-ready and assist with monitoring visits, sponsor audits, and inspections • Attend regulatory meetings, take minutes as needed, and provide updates on document status and submission timelines • Track expiration dates for approvals, licenses, and other time-sensitive documents • Assist with regulatory logs and tracking tools • Perform additional duties as needed to support the research program and organizational needs

🎯 Requirements

• Familiarity with FDA, ICH-GCP, and IRB regulatory requirements • Excellent organizational skills and attention to detail • Ability to manage multiple deadlines and prioritize tasks • Strong written and verbal communication skills • Professionalism when interacting with internal and external stakeholders • Proficiency in Microsoft Office Suite and regulatory document platforms, including CRIO, Complion, and Veeva • At least 1–3 years of experience in clinical research or regulatory affairs • Bachelor’s degree preferred, ideally in life sciences, healthcare, or a related field • Experience submitting documents to IRBs and maintaining regulatory binders in a clinical trial environment is preferred

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