Regional Regulatory Manager

🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Flourish Research

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Pharmaceuticals

Flourish Research is a national, multi-site clinical trial network and site operator that runs paid clinical studies across the United States. It provides end-to-end clinical research solutions — from first-in-human and early in-patient Phase I studies through Phase II–IV trials — and partners with pharmaceutical sponsors and CROs to accelerate trial execution using wholly-owned sites, experienced investigators, recruitment technology, and access to diverse and underrepresented patient populations. The company operates dozens of clinic locations across many U. S. states, specializes in therapeutic areas including cardiometabolic, oncology, neuroscience, infectious disease and vaccines, and emphasizes patient-centric care, high retention, and regulatory-quality study delivery.

📋 Description

• Oversee, manage, and coordinate regulatory documents and activities throughout clinical research studies across regional sites • Ensure compliance with company SOPs, policies, federal regulations, medical ethics, ICH, GCP, IRB requirements, and sponsor protocols • Work closely with site leadership, principal investigators, site staff, sponsors, CROs, and IRB staff • Provide guidance and support to ensure regulatory requirements and deadlines are met • Manage employee CVs and maintain current licenses and certifications on file • Serve as regulatory lead for audits and inspections • Oversee regulatory start-up timelines and staff for awarded clinical research trials • Prepare, submit, and maintain regulatory documents, including IRB submissions, amendments, and renewals • Provide administrative and regulatory guidance across the assigned region • Establish communication channels and disseminate key information among regulatory teams, site management, delegates, and RDO • Collaborate with management on staff development, department structure, and employee retention • Develop strategies, systems, and tools to improve regulatory efficiency and quality • Serve as regional subject matter expert • Manage assigned team activities to improve organizational performance • Lead, mentor, manage, and train team members • Assist with screening, interviewing, and hiring team members • Conduct annual performance reviews and foster continuous improvement • Identify trends and contribute to process improvement initiatives • Perform disciplinary procedures when necessary • Manage team time-off requests and schedules to ensure adequate staffing • Abide by HIPAA regulations and maintain sponsor confidentiality • Create error-free written documents and reports • Perform duties in a time- and cost-effective manner • Represent Flourish Research professionally when interacting with staff, clients, and vendors • Perform additional duties as assigned • Travel may be required up to 50% • Participate in participant care and monitor/sponsor customer service • Work occasional evening and weekend schedules

🎯 Requirements

• High School Diploma required • College degree preferred, but not required • Minimum of 5+ years’ experience in clinical or biological research • Minimum of 3 years in the department plus 2 years in a related role within the clinical research industry • Exceptional knowledge of clinical research methods • Strong management and leadership skills • Demonstrated ability to collaborate and align with operations • Excellent written and oral communication skills • Moral and ethical decision-making when interacting with patients, sponsors, IRB representatives, physicians, staff, and employees • Strong work ethic and commitment to accuracy and quality • Ability to develop and implement departmental initiatives • Ability to identify and implement process improvements • Ability to build and foster relationships across teams • Ability to serve as preceptor, mentor, and subject matter expert in the department • Strong critical thinking, decision-making, and sound judgment • Excellent computer skills, including Office365 products • Strong problem-solving, risk assessment, and impact analysis abilities • Demonstrated experience in process improvement • Flexibility and ability to multitask and prioritize competing demands • Ability to think independently and influence when appropriate

🏖️ Benefits

• Health, dental, and vision insurance plans • 401(k) with a 100% employer match on the first 4% of employee contributions • Tuition reimbursement • Parental leave • Employee referral program • Employee assistance program • Life insurance • Disability insurance • Generous PTO plan covering vacation, sick, personal days and 8 paid holidays