Regulatory Manager

The Regulatory Manager will be responsible for the planning, management, and execution of all regulatory activities for clinical research studies conducted at AMR. Oversight of regulatory team to ensure the complete and accurate performance of all regulatory activities in compliance with federal Food and Drug Administration (FDA) regulations. Responsible for developing strategies, processes, and metrics to ensure a high level of efficiency and quality are maintained for all regulatory activities.

To consistently embody AMR Clinical's Core Values:

• United We Achieve
• Celebrate Diverse Perspectives
• Do the Right Thing
• Adapt and Persevere

The Regulatory Manager reports to the Vice President of Project Delivery and Regulatory.

Classification: Exempt

Primary Responsibilities:

• Oversee the regulatory team's preparation, collection, and maintenance of essential documents for electronic regulatory binders.
• Oversee the IRB submissions for each protocol.
• Manage/troubleshoot electronic regulatory software.
• Advanced understanding of all active and upcoming studies.
• Proactively assess progress of regulatory document completion and IRB submissions/approval against overall study timelines.
• Leads team meetings to review progress of studies and provide regular updates to senior management.
• Meet with Project Manager and Study Start-up Team Lead to review statuses of studies in startup.
• Develop and implement utilization metrics to determine team assignments.
• Develop and maintain metrics for key performance indicators to monitor departmental efficiencies.
• Train new staff members in accordance with the training program to ensure staff's knowledge of and proficiency in applying and complying with standard operation procedures.
• Assure study team's compliance with FDA and ICH guidelines.
• Identify areas of risk to exposure and report targets to the Site Manager, Site GM, Vice President of Project Delivery and Regulatory along with recommendations for minimizing risk.
• Coordinate and support QA team in preparation of Sponsor and FDA audits.
• Oversee the maintenance of current information of PI and Sub- Investigators.
• Manage updating CVs of all staff and & annual providers licenses.
• Meet with Sponsors/CROs to ensure study timelines and expectations are being met.
• Ensure accurate and timely completion of all documents needed for submission to the Sponsor, CRO and IRB.
• Responsible for talent development within the team.
• Other duties as assigned

Desired Skills and Qualifications:

• Bachelor's degree preferred
• Advanced knowledge of the regulatory submission process and electronic regulatory software.
• Five to eight years of work experience in the regulatory field.
• Demonstrate interpersonal and leadership skills, including ability to effectively supervise individuals and teams.
• Strong understanding of FDA regulations and ICH guidelines.
• Ability to effectively devote keen and acute attention to detail.
• Ability to multi-task and perform multiple critical tasks simultaneously (under dynamic and ever-changing circumstances).
• Ability to function independently without constant supervision.
• Strong written and verbal communication skills.
• Advanced knowledge of computer operations, computer skills, i.e., Word and Excel.
• Understanding and compliance of Good Clinical Practice Guidelines i.e.: completion of training, testing and application.
• Ability to effectively communicate with Sponsors, CROs, monitors, IRBs, and clinical sites.
• Fluent in English.

AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.

** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.