Regional Regulatory Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise, manage, and coordinate regulatory documents and activities throughout clinical research studies at various regional sites.

• Ensure adherence to company SOPs, policies, federal regulations, medical ethics, ICH, GCP, IRB requirements, and sponsor protocols.

• Collaborate closely with site leadership, principal investigators, site personnel, sponsors, CROs, and IRB staff.

• Offer guidance and support to guarantee that regulatory requirements and deadlines are satisfied.

• Manage employee CVs and keep current licenses and certifications on file.

• Act as the regulatory lead during audits and inspections.

• Oversee regulatory start-up timelines and personnel for awarded clinical research trials.

• Prepare, submit, and maintain regulatory documents, including IRB submissions, amendments, and renewals.

• Provide administrative and regulatory guidance throughout the assigned region.

• Establish communication channels and relay key information among regulatory teams, site management, delegates, and RDO.

• Work with management on staff development, department structure, and employee retention.

• Develop strategies, systems, and tools to enhance regulatory efficiency and quality.

• Serve as a regional subject matter expert.

• Manage the activities of assigned team members to boost organizational performance.

• Lead, mentor, manage, and train team members.

• Assist in screening, interviewing, and hiring team members.

• Conduct annual performance evaluations and promote continuous improvement.

• Identify trends and contribute to initiatives for process improvement.

• Carry out disciplinary procedures when necessary.

• Manage team time-off requests and schedules to ensure adequate staffing.

• Comply with HIPAA regulations and maintain sponsor confidentiality.

• Generate error-free written documents and reports.

• Execute duties in a time- and cost-effective manner.

• Represent Flourish Research professionally during interactions with staff, clients, and vendors.

• Perform additional tasks as assigned.

• Travel may be required up to 50%.

• Engage in participant care and monitor/sponsor customer service.

• Occasionally work evenings and weekends.

⛳️ Requirements

• High School Diploma is required.

• A college degree is preferred but not mandatory.

• At least 5+ years of experience in clinical or biological research.

• Minimum of 3 years in the department plus 2 years in a related role within the clinical research field.

• Exceptional understanding of clinical research methodologies.

• Strong leadership and management capabilities.

• Proven ability to collaborate and align with operational teams.

• Excellent written and verbal communication skills.

• Ethical decision-making skills when interacting with patients, sponsors, IRB representatives, physicians, staff, and colleagues.

• Strong work ethic with a focus on accuracy and quality.

• Capacity to develop and implement departmental initiatives.

• Ability to identify and execute process improvements.

• Proficiency in building and nurturing relationships across teams.

• Capability to serve as a preceptor, mentor, and subject matter expert within the department.

• Strong critical thinking, decision-making, and sound judgment skills.

• Excellent computer proficiency, particularly with Office365 products.

• Strong problem-solving, risk assessment, and impact analysis skills.

• Demonstrated experience in process enhancement.

• Flexibility with the ability to multitask and prioritize competing demands.

• Ability to think independently and influence others 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.