Senior Staff Regulatory Affairs/Quality Compliance Specialist, Pharmaceuticals (Remote)

About the Role

This is a remote position located anywhere within the United States. As the Senior Staff Regulatory Affairs/Quality Compliance Specialist, you will provide leadership for global regulatory submissions, quality management system oversight, audit readiness, and compliance initiatives supporting pharmaceutical products and clinical investigations. Working across development, manufacturing, quality, and regulatory functions, you will help ensure products and processes meet applicable regulatory and quality requirements throughout their lifecycle.

Responsibilities

• Develop and execute global regulatory strategies to support clinical investigations, product registrations, and post-approval changes for pharmaceutical products.
• Prepare, review, and submit regulatory documentation, including clinical trial applications, marketing applications, manufacturing dossiers, and post-approval submissions.
• Maintain and continuously improve the Pharmaceutical Quality Management System (QMS), ensuring compliance, efficiency, and inspection readiness.
• Lead internal and supplier audits, document findings, monitor corrective actions, and support audit program effectiveness.
• Analyze quality system metrics and trends, prepare Annual Product Quality Reviews, and present findings to management.
• Lead nonconformance and corrective and preventive action (CAPA) activities, including investigation, implementation, effectiveness verification, and documentation.
• Author, review, and approve quality system procedures, work instructions, forms, and quality plans while delivering QMS training across the organization.
• Collaborate with regulatory agencies and cross-functional teams to support submissions, regulatory inquiries, manufacturing changes, and compliance activities.

Requirements

• Bachelor’s degree.
• 6+ years of experience in a pharmaceutical, biotechnology, or other FDA and/or Health Canada regulated industry.
• 6+ years of experience in pharmaceutical regulatory affairs, quality systems, or quality compliance.
• Experience preparing regulatory submissions and supporting product approvals, clinical study applications, or post-approval regulatory activities.

Preferred Qualifications

• Certificate in Regulatory Affairs.
• Lead Auditor certification.
• Experience working within Good Manufacturing Practice (GMP) environments.
• Experience with pharmaceutical quality management systems, audits, CAPA management, and regulatory inspections.

Pay

Annual pay ranges (USD):

• USN: $110,100 - $183,400
• US5: $115,600 - $192,600
• US10: $121,100 - $201,700
• US15: $126,600 - $210,900
• US20: $132,100 - $220,100
• US30: $143,100 - $238,400

View the U.S. work location and transparency guide to find the pay range for your location.

Benefits

Health benefits include:

• Medical and prescription drug insurance
• Dental insurance
• Vision insurance
• Critical illness insurance
• Accident insurance
• Hospital indemnity insurance
• Personalized healthcare support
• Wellbeing program and tobacco cessation program

Financial benefits include:

• Health Savings Account (HSA)
• Flexible Spending Accounts (FSAs)
• 401(k) plan
• Employee Stock Purchase Plan (ESPP)
• Basic life and AD&D insurance
• Short-term disability insurance

Depending on customer requirements, employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.