Senior Regulatory Affairs Lead - Alzheimer Platform Trial

1200 The General Hospital Corporation; Somerville (MA); Hybrid; USD 51,000 - 82,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Job summary

Mass General Brigham is seeking an experienced Regulatory Affairs Coordinator for a nationwide Alzheimer's platform trial within the McCance Center. You will serve as the Center’s regulatory expert, leading regulatory risk management, planning, and regulatory operations for the clinical trial program.

Working closely with leadership, investigators, IRBs, and sponsors, you will provide regulatory guidance, ensure compliance, prepare essential documents, and mentor staff on regulatory requirements

Qualifications

• Regulatory requirements for clinical research, including FDA regulations.
• Experience with IRBs, regulatory submissions, and regulatory documentation.
• Strong organizational and project management skills.

Responsibilities

• Ensure all research activities, documents, and processes adhere to relevant regulations.
• Oversee the preparation, submission, and tracking of study-related documents to the IRB.
• Prepare and maintain essential regulatory documents (investigator brochures, consent forms, study protocols).
• Collaborate with research teams to initiate studies, including regulatory document collection and site activation.
• Support audits related to regulatory compliance and documentation.
• Oversee adverse event reporting and safety monitoring.

Skills

Regulatory affairs

FDA regulations

Clinical trial regulatory

Project management

Communication

Education

Bachelor's Degree Healthcare Management

Bachelor's Degree Related Field of Study

Master's Degree Related Field of Study

Job description

Mass General Brigham is seeking an experienced Regulatory Affairs Coordinator for a nationwide Alzheimer's platform trial within the McCance Center. You will serve as the Center’s regulatory expert, leading regulatory risk management, planning, and regulatory operations for the clinical trial program.

Working closely with leadership, investigators, IRBs, and sponsors, you will provide regulatory guidance, ensure compliance, prepare essential documents, and mentor staff on regulatory requirements