Manager, Research Regulatory Programs, Gerontology

JOB SUMMARY

The Manager, Research Regulatory Programs provides strategic oversight and coordination of regulatory compliance, policies, and programs across multiple research studies and clinical trials. This role ensures adherence to Institutional Review Board (IRB) requirements, FDA regulations, and HIPAA compliance while offering expert guidance to principal investigators (PIs) and research staff. As a supervisor, the Senior Regulatory Specialist leads regulatory efforts, mentors junior staff, and plays a critical role in regulatory submissions and FDA-related activities, including investigational new drug (IND) and investigational device exemption (IDE) applications. The position requires sound judgment and discretion, functioning with minimal supervision to support research objectives.

EDUCATION / EXPERIENCE

Required:

• Bachelor’s degree in a relevant field (e.g., Health Administration, Nursing, Psychology, Biological Sciences, or a related discipline).
• Minimum of five (5) years of experience in regulatory affairs within clinical research, with a focus on FDA-regulated studies.

Preferred:

• Master’s degree in a related discipline.
• Experience in an academic medical research environment , preferably within hospital or medical school settings.

LICENSURE/CERTIFICATION

• Certification from the Society of Clinical Research Associates (SOCRA) or the Association of Clinical Research Professionals (ACRP) is preferred.

ESSENTIAL FUNCTIONS

1. Regulatory Oversight & Compliance:

• Serve as the departmental subject matter expert (SME) , providing advanced regulatory guidance to ensure compliance with IRB standard operating procedures (SOPs), HIPAA regulations, and federal regulatory requirements (e.g., FDA, NIH, HHS, OSHA ).
• Oversee the preparation, submission, and maintenance of regulatory documents, including IRB applications, FDA Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications , amendments, and continuing reviews.
• Ensure adherence to Good Clinical Practices (GCP), International Council for Harmonisation (ICH) guidelines, and FDA submission standards , maintaining an audit-ready state for all studies.
• Advise investigators and study teams on regulatory pathways, assisting with pre-IND and pre-IDE meetings and correspondence with regulatory agencies.

2. Supervisory & Leadership Responsibilities:

• Provide direct supervision and mentorship to regulatory team members, ensuring adherence to policies and procedures while fostering professional growth.
• Manage team performance, including conducting evaluations, providing feedback, and developing staff training plans to improve regulatory competency.
• Oversee recruitment, onboarding, and performance management of regulatory personnel to ensure optimal department functioning.
• Assign tasks and allocate resources efficiently to meet departmental goals and study deadlines.

3. Audit Readiness & Quality Assurance:

• Lead the preparation and coordination of FDA audits, sponsor inspections, and internal/external regulatory audits , ensuring adherence to compliance standards.
• Develop and implement risk assessment strategies and quality assurance initiatives to proactively address potential compliance gaps.
• Maintain complete and accurate regulatory documentation, including SOPs, informed consent forms, and study logs to meet FDA and institutional requirements.

4. Clinical Operations & Study Management:

• Collaborate with PIs, project managers, and clinical teams to ensure trials comply with protocol specifications and regulatory commitments.
• Establish workflows for data collection, reporting, and regulatory submissions to align with sponsor expectations and FDA requirements.
• Provide operational oversight for study initiation, conduct, and close-out, ensuring proper documentation and regulatory compliance.

5. FDA Submission & Reporting:

• Oversee the preparation and submission of FDA-related documents, including:
  • IND/IDE applications
  • Annual progress reports
  • Safety reports and adverse event submissions (SAEs, SUSARs)
  • Clinical trial registration and results reporting to ClinicalTrials.gov
• Collaborate with biostatistics and clinical teams to ensure compliance with FDA data requirements and submission timelines.

6. Training & Staff Development:

• Develop and conduct comprehensive training programs for research staff on FDA regulations, IRB requirements, and best practices in regulatory compliance.
• Provide ongoing education on regulatory changes, ensuring the department remains up to date with evolving FDA guidelines and industry standards.
• Mentor junior regulatory staff, providing guidance on complex submissions and regulatory pathways.

7. Stakeholder & Sponsor Relations:

• Establish and maintain strong working relationships with sponsors, regulatory agencies, and affiliate organizations to facilitate study operations and compliance.
• Represent the department at sponsor meetings, national conferences, and regulatory working groups to advocate for best practices and regulatory excellence.

8. Operational Leadership & Special Projects:

• Contribute to the development and execution of long-term strategic initiatives to enhance regulatory efficiency and compliance.
• Prepare operational reports and analyses, identifying trends, challenges, and solutions for regulatory process improvements.
• Participate in internal and external committees to support institutional objectives and regulatory innovation.

SKILLS / QUALIFICATIONS

• Extensive knowledge of clinical research methodologies, FDA regulations, and human subject protection standards.
• Strong leadership and team management abilities, with a demonstrated ability to supervise and mentor staff effectively.
• Excellent verbal and written communication skills, with the ability to convey complex regulatory concepts to diverse audiences.
• Ability to independently interpret and summarize complex regulatory requirements succinctly.
• Proficiency in software platforms is preferred
  • ERP (Oracle, Workday, NetSuite)
  • Microsoft Office Suite (Word, Excel, Outlook, Teams, SharePoint)
  • Electronic Health Record System
  • Clinical Trial Management System
• Strong organizational, problem-solving, and decision-making skills with exceptional attention to detail.
• Familiarity with institutional and federal regulatory frameworks, including GCP and ICH guidelines.
• Ability to manage multiple priorities and meet strict deadlines in a fast-paced research environment.

WORK ENVIRONMENT

• Office-based environment with regular interaction with investigators, research staff, and sponsors.
• Occasional travel required for site visits, sponsor meetings, and regulatory conferences.