Regional Regulatory Manager

Flourish Research

. Oversee, manage, and coordinate regulatory documents and activities throughout clinical research studies across regional sites .

Posted 9/18/2026full-timeRemote • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive knowledge of clinical research methods and regulatory compliance, with strong leadership and management capabilities to oversee teams and ensure adherence to federal regulations and ethical standards.

Highest-signal resume keywords

Clinical Research MethodsRegulatory ComplianceLeadership SkillsProcess ImprovementCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Document ManagementIRB SubmissionsClinical Research ExperienceSOP ComplianceData AnalysisRisk AssessmentQuality AssuranceProject ManagementTime ManagementPerformance Review

Soft Skills

CollaborationCritical ThinkingDecision-MakingMentoringInterpersonal Skills

Tools & Technologies

Office365

Industry Keywords

ICHGCPIRBCROHIPAAClinical TrialsMedical EthicsSponsor Protocols

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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