Senior Regulatory Affairs and Compliance Specialist

University of Rochester; United States; On-site; USD 71,000 - 106,000; Full time

Job summary

University of Rochester is seeking a Senior Regulatory Affairs and Compliance Specialist in Rochester, NY, to oversee regulatory submissions, compliance, and quality systems for clinical research across the university. The role involves coordinating regulatory processes, ensuring FDA IND/IDE adherence, and interacting with investigators, sponsors, and administrators.

The position requires strategic leadership in regulatory support, coordination of sponsor communications, and management of

Qualifications

• Experience with regulatory submissions and compliance for clinical studies.
• Ability to liaise with investigators, sponsors and administrators.
• Understanding of FDA IND/IDE regulations.

Responsibilities

• Oversees strategic regulatory oversight and compliance for clinical studies.
• Manages regulatory submissions and quality systems.
• Coordinates regulatory processes for Sponsor-Investigator studies.
• Liaises with PIs, sponsors, and administrators for contracts and sponsor receivables.

Skills

Regulatory affairs

Regulatory submissions

Stakeholder management

Quality systems

Job description

Job Location (Full Address):

265 Crittenden Blvd, Rochester, New York, United States of America, 14642

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400990 Clin & Trans Science Institute

Work Shift:

UR - Day (United States of America)

Range:

UR URG 112

Compensation Range:

$70,600.00 - $105,800.00

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities:

Responsible for strategic oversight, complex regulatory submissions and compliance, quality system management, and high-level stakeholder interaction, the Senior Regulatory Affairs and Compliance specialist directs the planning, implementation, coordination, operation, and evaluation of administrative and regulatory requirements leading to regulatory approval and regulatory maintenance of clinical research studies across the university. Ensures strict adherence to FDA Investigational New Drug (IND) and Investigational Device Exemption (IDE) regulations. Coordinates regulatory processes for new and ongoing studies. Oversees compliance with and effectiveness of Clinical Research procedures and study documentation requirements from multiple sponsors and agencies. Establishes and monitors standard operating procedures (SOPs). Liaises with Principal Investigators (PIs), sponsors, and administrators to assist with program contract development, financial negotiations, and sponsor receivables.

ESSENTIAL FUNCTIONS

Coordinates regulatory processes for new and ongoing SponsorInvestigator studies following university, state and /or federal regulations and guidelines. Evaluates study regulatory needs based on grant requirements and prepares documents and submissions to the FDA and for submission to ClinicalTrials.gov, institutional ancillary review requirements, clinical trial management requirements, National Institutes of Health (NIH) certificates of confidentiality, and other agencies as needed. Conducts orientation meetings with various teams particular to each study. Manages ongoing regulatory requirements for active studies, including but not limited to protocol amendments, annual reports and amendments to the FDA, and oversees study closures. Responsible for reporting requirements. Manages maintenance of regulatory documentation database.

Oversees compliance with and effectiveness of Clinical Research procedures and study documentation requirements from multiple sponsors and agencies. Ensures process and documentation of ongoing studies meet all internal and external audit guidelines. Ensures regulatory and other essential documents are current and on file for regulatory review. Maintains and tracks study personnel certification and current central and local lab facility certifications.

Serves as primary contact for developing Quality Assurance Unit standard operating procedures (SOP). Conducts semi-annual SOP audits to verify procedures and equipment's accuracy and ensure compliance with institutional and sponsor requirements. Assists with developing corrective and preventative action plans (CAPA) and submits to FDA as required.

Liaises with principal investigators, sponsors, Office of Counsel, ORPA, UR Ventures and administrators to assist with program contract development and negotiations, study startup, and communication of regulatory updates. Develops and maintains relationships with sponsors, CROs, regulatory agencies, site coordinators, and other University clinical and operational areas/departments. Works with the Director, Office of Regulatory Support to review regulatory requirements against protocol on new studies as needed. Handles site interest/qualifications surveys and reviews/develops new contracts with program senior management.

Provides strategic leadership and comprehensive oversight for clinical services and investigational products, ensuring strict adherence to FDA Investigational New Drug (IND) and Investigational Device Exemption (IDE) regulations, Good Clinical Practice (GCP) guidelines, and institutional policies. Key responsibilities include: managing institutional portfolio of Sponsor-Investigator regulatory submissions, ensuring adherence to federal regulations regarding ClinicalTrials.gov study registration and results reporting, and collaborating with key stakeholders for best practices and qu