Director, Regulatory Affairs

The Director of Regulatory Affairs provides strategic and operational leadership for the regulatory function across ERA Health Research. This role ensures regulatory excellence across all clinical trials while enabling efficient study startups, maintaining continuous inspection readiness, and building scalable regulatory systems to support ERA’s expanding clinical trial portfolio. The Director leads the regulatory team, oversees regulatory submissions and documentation, and partners closely with Clinical Operations, Quality, Investigators, and Sponsors to ensure compliant and efficient trial execution.This role also supports a growing portfolio of clinical trials conducted across ERA Health Research’s clinical research operations and oversees regulatory processes supporting multiple concurrent studies across various therapeutic areas, helping build scalable regulatory systems to support continued organizational growth.First-year prioritiesStrengthen ERA’s regulatory infrastructure to support a growing clinical trial portfolioImprove study startup timelines and regulatory submission efficiencyEnsure continuous inspection readiness across all studiesBuild scalable regulatory systems and documentation standardsDevelop a high-performing regulatory team with clear processes and accountabilityDUTIES & RESPONSIBILITIESRegulatory Strategy and LeadershipLead the regulatory function across ERA Health Research ensuring compliance with federal, state, and institutional regulationsDevelop regulatory strategies that support efficient trial execution and rapid study startupBuild scalable regulatory systems and processes to support growth of ERA’s clinical trial networkEstablish regulatory performance metrics including startup timelines and submission turnaroundServe as the internal subject matter expert on regulatory complianceRegulatory Operations and Study SupportOversee preparation and submission of regulatory documents to Institutional Review Boards (IRBs)Ensure timely completion of study startup documents, amendments, continuing reviews, safety reports, and study close-out documentationMaintain accurate and complete regulatory files in accordance with Good Clinical Practice (GCP)Partner with Clinical Operations to ensure regulatory alignment throughout the study lifecycleSupport protocol feasibility and regulatory assessment during study selection and startupInspection Readiness and QualityMaintain continuous inspection readiness across all studiesLead regulatory preparation for sponsor audits, internal audits, and regulatory inspections including FDA inspectionsPartner with Quality Assurance leadership to address compliance findings and implement CAPAsRegulatory Team LeadershipRecruit, mentor, and develop regulatory staffDesign and scale the regulatory organization to support ERA’s expanding clinical trial portfolioManage regulatory workload prioritization and resource allocationEstablish training and professional development programs for regulatory staffSponsor and CRO CollaborationServe as a primary regulatory contact for sponsors and CROsPartner with sponsors and CROs to ensure regulatory requirements are clearly defined and executedSupport contract and budget review to ensure regulatory obligations are appropriately addressedRepresent ERA Health Research in sponsor meetings and regulatory discussionsAdditional ResponsibilitiesWork with the leadership team and HR to ensure alignment with the organization’s strategic planPerform other duties as assigned. These additional duties will fall within the scope of the role and contribute to the overall success of the teamQUALIFICATIONSREQUIREDBachelor’s degree in regulatory affairs, life sciences, clinical research, or a related field5 years leading regulatory teams in clinical research5 years of regulatory affairs experience within clinical research, pharmaceutical, or biotechnology industriesStrong knowledge of GCP, ICH guidelines, FDA clinical research regulations, and IRB processesDemonstrated ability to manage multiple studies and regulatory submissions simultaneouslyStrong leadership, communication, and cross-functional collaboration skillsPreferredExperience working in a clinical trial site or site networkExperience supporting FDA inspections or regulatory authority auditsProfessional certification such as ACRP or SOCRAExperience building or scaling regulatory operationsPAY & BENEFITSPay Range: $160,000.00/annually - $ 180,000.00/annuallyPay is based upon candidate experience and qualifications, as well as market and business considerations.ERA Health Research provides eligible employees with an opportunity to enroll in a comprehensive benefits package which includes:Medical, dental, and vision insuranceFlexible Spending Account (FSA) and Health Savings Account (HSA) options401k Retirement Savings PlanPaid time off (PTO) and 1 hour of sick leave for every 40 hours worked2 Floating Holidays per yearEEO STATEMENTERA Health Research provides equal employment opportunities to all without regard to race, color, religion, sex (including sexual orientation or gender identity), national origin, age, disability, genetic information, or other protected status. Applicants and employees with disabilities may be entitled to reasonable accommodations under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is an adjustment to our standard application and/or interview and/or employment process which will ensure an equal employment opportunity without imposing undue hardship on ERA Health Research. Please inform our team if you are requesting accommodation to complete any forms or otherwise participate in the application process or perform the essential functions of this role.

Salary : $160,000 - $180,000