Regulatory Specialist

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🕒 3 days ago

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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

• Assist in preparing and submitting regulatory documents to IRBs, sponsors, and internal stakeholders including initial submissions, amendments, continuing reviews, and safety reports • Maintain and update Investigator Site Files (ISFs), regulatory binders, and electronic systems to ensure documents are current and properly filed • Help coordinate collection and submission of start-up documents such as site questionnaires, training logs, CVs, and delegation logs • Ensure documentation complies with ICH-GCP, FDA regulations, and sponsor-specific requirements • Serve as a liaison between research staff, investigators, sponsors, and IRBs to facilitate timely and accurate regulatory processes • Keep regulatory files audit-ready and assist with preparation and support during monitoring visits, sponsor audits, or 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

🎯 Requirements

• Bachelor’s degree preferred, ideally in life sciences, healthcare, or a related field • At least 1–3 years of experience in clinical research or regulatory affairs • Excellent organizational skills and attention to detail • Ability to manage multiple deadlines and prioritize tasks • Strong written and verbal communication skills

🏖️ Benefits

• Professionalism when interacting with internal and external stakeholders • Proficiency in Microsoft Office Suite and regulatory document platforms (e.g., CRIO, Complion, Veeva)