Director of Regulatory Affairs
Era Health Research, LLC, Redmond, WA, United States
Salary Range: $160,000.00 To $180,000.00 Annually
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.
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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.
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