Manager – Regulatory Affairs

Job not on LinkedIn

🔥 2 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 17%

What it means: how likely this posting is sitting open without active hiring.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

• Lead the centralized regulatory function for Prolerity Clinical Research’s multisite clinical-trial network • Manage regulatory staff and own regulatory readiness from site selection through activation, study maintenance, and closeout • Provide hands-on oversight of daily regulatory work, submissions, document review, and issue resolution • Lead regulatory startup, establish study ownership and timelines, and define submission responsibilities • Prepare and quality-check regulatory packets, including Form FDA 1572 or investigator agreements, CVs, licenses, training records, financial disclosures, and localized informed consent forms • Coordinate sponsor review and Central IRB submissions; track approvals, outstanding documents, and activation dependencies • Partner with investigators, site leadership, clinical operations, contracts and budgets, sponsors, CROs, and Central IRBs to resolve startup barriers • Verify approvals, training, documentation, and sponsor authorization before participant consent and study activities begin • Manage amendments through submission and implementation, including document distribution, staff training, re-consent, and version retirement • Coordinate regulatory requirements for investigator transitions and study staff changes • Oversee safety submissions, reportable events, continuing reviews, IRB correspondence, study closeout, and record retention • Track credential and document expirations and obtain updates before lapse • Conduct regulatory quality reviews and support monitoring visits, sponsor audits, and FDA inspections • Lead corrective and preventive actions for regulatory findings • Coordinate qualification, agreements, and regulatory documentation for external laboratories, imaging centers, and outsourced providers • Maintain central laboratory, imaging, and sponsor-vendor documentation • Supervise, coach, and develop regulatory specialists; balance workloads and manage performance • Provide onboarding and continuing training and maintain SOPs, templates, checklists, and sponsor-specific guidance • Oversee regulatory communications, study trackers, and electronic regulatory systems • Report cycle times, blocked items, document completeness, and compliance trends to leadership • Implement measurable process improvements and establish consistent startup and training workflows

🎯 Requirements

• More than five years of site-side clinical trial regulatory experience at an investigative site, site network, or site management organization • Startup ownership for industry-sponsored drug studies • At least three years of leadership experience, including staff supervision, coaching, workload management, and accountability for results • Hands-on experience with Central IRB submissions, consent localization, essential regulatory documents, and amendment management • Strong working knowledge of applicable FDA requirements, ICH Good Clinical Practice, and human subject protections • Experience coordinating documentation for laboratories, imaging centers, or other outsourced study procedures • Experience developing regulatory processes adopted by a team • Strong communication, organizational, and problem-solving skills • Ability to manage competing priorities remotely • Ability to travel approximately 20% • Experience with CRIO, Complion, and other electronic regulatory or investigator site file systems preferred • Experience supporting medical device studies, a multisite or multistate network, and sponsor audits or FDA inspections preferred • Bachelor’s degree in a life science or related field, or equivalent relevant experience • ACRP or SOCRA certification preferred • RAPS RAC certification is a plus

🏖️ Benefits

• Fully remote work arrangement • Approximately 20% travel to sites across the South, Southeast, and Northeast • Training and continuing development opportunities • Staff coaching and professional development • Leadership responsibility and process improvement ownership