Director, Regulatory Affairs at ERA Health Research

Redmond, Washington, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Jun, 26

Salary

180000.0

Posted On

06 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Clinical Trials, Regulatory Submissions, Inspection Readiness, GCP Compliance, IRB Oversight, Regulatory Leadership, Team Development, Protocol Feasibility, CAPA Implementation, Sponsor Collaboration, CRO Partnership, Regulatory Documentation, Study Startup Efficiency, Resource Allocation, Life Sciences

Industry

Research Services

Description

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 priorities * Strengthen ERA’s regulatory infrastructure to support a growing clinical trial portfolio * Improve study startup timelines and regulatory submission efficiency * Ensure continuous inspection readiness across all studies * Build scalable regulatory systems and documentation standards * Develop a high-performing regulatory team with clear processes and accountability DUTIES & RESPONSIBILITIES Regulatory Strategy and Leadership * Lead the regulatory function across ERA Health Research ensuring compliance with federal, state, and institutional regulations * Develop regulatory strategies that support efficient trial execution and rapid study startup * Build scalable regulatory systems and processes to support growth of ERA’s clinical trial network * Establish regulatory performance metrics including startup timelines and submission turnaround * Serve as the internal subject matter expert on regulatory compliance Regulatory Operations and Study Support * Oversee 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 documentation * Maintain accurate and complete regulatory files in accordance with Good Clinical Practice (GCP) * Partner with Clinical Operations to ensure regulatory alignment throughout the study lifecycle * Support protocol feasibility and regulatory assessment during study selection and startup Inspection Readiness and Quality * Maintain continuous inspection readiness across all studies * Lead regulatory preparation for sponsor audits, internal audits, and regulatory inspections including FDA inspections * Partner with Quality Assurance leadership to address compliance findings and implement CAPAs Regulatory Team Leadership * Recruit, mentor, and develop regulatory staff * Design and scale the regulatory organization to support ERA’s expanding clinical trial portfolio * Manage regulatory workload prioritization and resource allocation * Establish training and professional development programs for regulatory staff Sponsor and CRO Collaboration * Serve as a primary regulatory contact for sponsors and CROs * Partner with sponsors and CROs to ensure regulatory requirements are clearly defined and executed * Support contract and budget review to ensure regulatory obligations are appropriately addressed * Represent ERA Health Research in sponsor meetings and regulatory discussions Additional Responsibilities * Work with the leadership team and HR to ensure alignment with the organization’s strategic plan * Perform other duties as assigned. These additional duties will fall within the scope of the role and contribute to the overall success of the team QUALIFICATIONS REQUIRED * Bachelor’s degree in regulatory affairs, life sciences, clinical research, or a related field * 5+ years leading regulatory teams in clinical research * 5+ years of regulatory affairs experience within clinical research, pharmaceutical, or biotechnology industries * Strong knowledge of GCP, ICH guidelines, FDA clinical research regulations, and IRB processes * Demonstrated ability to manage multiple studies and regulatory submissions simultaneously * Strong leadership, communication, and cross-functional collaboration skills Preferred * Experience working in a clinical trial site or site network * Experience supporting FDA inspections or regulatory authority audits * Professional certification such as ACRP or SOCRA * Experience building or scaling regulatory operations PAY & BENEFITS Pay Range: $160,000.00/annually - $ 180,000.00/annually Pay 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 insurance * Flexible Spending Account (FSA) and Health Savings Account (HSA) options * 401k Retirement Savings Plan * Paid time off (PTO) and 1 hour of sick leave for every 40 hours worked * 2 Floating Holidays per year EEO STATEMENT ERA 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.

Responsibilities

The Director of Regulatory Affairs provides strategic and operational leadership for the regulatory function, ensuring compliance across all clinical trials while enabling efficient study startups and maintaining continuous inspection readiness. This role involves leading the regulatory team, overseeing submissions, and partnering with clinical operations and quality to ensure compliant and efficient trial execution across a growing portfolio.