Remote Regional Regulatory Manager

Flourish Research; Northern (KY); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with company match

Tuition reimbursement

Parental leave

Employee referral program

Employee assistance program

Life insurance

Disability insurance

PTO

Job summary

Flourish Research in the United States is seeking a Regional Regulatory Manager to oversee regulatory documents and activities for all clinical studies conducted by the regional sites. This remote role supports multiple sites and requires strong collaboration with site leadership, sponsors, and CROs.

This position involves IRB submissions, amendments, renewals, and audits, ensuring compliance with ICH/GCP, SOPs, and sponsor requirements while guiding a regulatory team and driving efficient

Qualifications

• Strong knowledge of regulatory requirements for clinical research.
• Experience leading regulatory activities across multiple sites.
• Ability to interact with sponsors, CROs, IRB staff and site leadership.

Responsibilities

• Oversee regulatory documents and activities for all studies in the region.
• Lead audits and inspections and ensure compliance with SOPs, ICH/GCP, and IRB requirements.
• Direct submissions, amendments, and renewals of regulatory documents; maintain high-quality records.
• Mentor regulatory staff and collaborate with site leadership and sponsors to improve processes.

Skills

Regulatory affairs

ICH/GCP knowledge

IRB submissions

Audits & inspections

SOP compliance

Team leadership

Education

Bachelor's degree in life sciences

Tools

Office365

Job description

Flourish Research in the United States is seeking a Regional Regulatory Manager to oversee regulatory documents and activities for all clinical studies conducted by the regional sites. This remote role supports multiple sites and requires strong collaboration with site leadership, sponsors, and CROs.

This position involves IRB submissions, amendments, renewals, and audits, ensuring compliance with ICH/GCP, SOPs, and sponsor requirements while guiding a regulatory team and driving efficient