Remote Regional Regulatory Lead

Socket.dev; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) retirement plan

Tuition reimbursement

Parental leave

Employee referral program

Employee assistance program

Life insurance

Disability insurance

Generous PTO

Job summary

Flourish Research is seeking a Regional Regulatory Manager to lead regulatory activities for multi-site clinical studies across the United States. This remote role requires coordinating IRB submissions, amendments, and sponsor communications while ensuring ICH/GCP and HIPAA compliance.

You will mentor the regulatory team, manage audits, and collaborate with site leadership, Sponsors, CROs and IRB staff to help start-up and sustain trials efficiently.

Qualifications

• 5+ years’ experience in clinical or biological research.
• Experience in regulatory affairs for clinical trials.
• Strong management and leadership skills.
• Excellent interpersonal and written/oral communication.
• Ability to mentor and precept staff.
• Knowledge of HIPAA regulations.

Responsibilities

• Provide guidance to ensure regulatory requirements and deadlines are met.
• Regulatory lead for audits and inspections.
• Oversee regulatory start-up timelines and staff.
• Maintain IRB submissions, amendments, and renewals.
• Develop strategies with site and regulatory teams to improve efficiency.
• Ensure quality and compliance across assigned region.

Skills

Regulatory leadership

Clinical research knowledge

Audits & inspections

Team mentoring

Interpersonal skills

Regulatory strategy

Communication

Education

High School Diploma

College degree preferred

Tools

Office365

Job description

Flourish Research is seeking a Regional Regulatory Manager to lead regulatory activities for multi-site clinical studies across the United States. This remote role requires coordinating IRB submissions, amendments, and sponsor communications while ensuring ICH/GCP and HIPAA compliance.

You will mentor the regulatory team, manage audits, and collaborate with site leadership, Sponsors, CROs and IRB staff to help start-up and sustain trials efficiently.