Job Description
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 reportsSafety reports and adverse event submissions (SAEs, SUSARs)Clinical trial registration and results reporting to ClinicalTrials.govCollaborate 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 preferredERP (Oracle, Workday, NetSuite)
Microsoft Office Suite (Word, Excel, Outlook, Teams, SharePoint)Electronic Health Record SystemClinical Trial Management SystemStrong 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.About Us
Wake Forest University School of Medicine (WFUSM) is a U.S. News and World Report top 50 ranked medical school, integrated with a world-class health system, Atrium Health. WFUSM, the academic core of Atrium Health Enterprise, is a recognized leader in experiential medical education and groundbreaking research that includes Wake Forest Innovations, a commercialization enterprise focused on advancing health care through new medical technologies and biomedical discovery. WFUSM, has over $300M in annual, extramural funding that drives a cutting-edge Academic Learning Health System by integrating innovative research with excellent patient care across our enterprise.
Atrium Health Wake Forest Baptist is based in Winston-Salem, North Carolina and is part of Advocate Health, which is headquartered in Charlotte, North Carolina, and is the fifth-largest nonprofit health system in the United States, created from the combination of Atrium Health and Advocate Aurora Health. AHWFB is an 885-bed tertiary-care hospital in Winston-Salem - that includes Brenner Children's Hospital, five community hospitals, more than 300 primary and specialty care locations and more than 2,700 physicians. Our highly integrated academic and clinical environment is deeply committed to improving health, elevating hope, and advancing healing - for all.
It should be noted that while you are applying on the Wake Forest University School of Medicine Career Site, you will receive communications from the Atrium Health Recruitment Team. Please know that this is an expected process. Thanks in advance for your flexibility.
About the Team
Mission, Vision and Culture Commitments
Mission
To improve health, elevate hope and advance healing - for all.
Vision
To be the first and best choice for care.
Culture Commitments
We create a space where all Belong
We Work as One to make great things happen
We earn Trust in all we do
We Innovate to better the now and create the future
We drive for Excellence - always
