Regulatory Operations Associate

Piper Companies is currently looking for a Regulatory Operations Associate in the Bethesda, MD area to work a hybrid role. The Regulatory Operations Associate will join a mission-driven organization focused on delivering research, technical, and operational solutions that help advance healthcare innovation.

Responsibilities for the Regulatory Operations Associate:

• Prepare and support regulatory filing documentation, ensuring timely distribution to appropriate stakeholders.
• Maintain both electronic and hard-copy filing systems to support regulatory compliance and audit readiness.
• Draft, revise, format, and distribute documents using established templates, procedures, and work instructions.
• Create and maintain process improvement tools, including templates, SOPs, work instructions, and checklists, to enhance efficiency and consistency.
• Monitor regulatory activities, update tracking systems and databases, and ensure documentation remains accurate and up to date.
• Provide general administrative and operational support for regulatory affairs activities as required

Qualifications for the Regulatory Operations Associate:

• Bachelor's Degree
• Excellent organizational and communication skills
• Preferred experience publishing regulatory submissions through electronic submission platforms and preparing documents in compliance with electronic submission requirements.
• Demonstrated ability to exercise sound judgment, take initiative, and effectively prioritize competing projects and deadlines.
• Knowledge of Good Clinical Practice (GCP) guidelines and/or experience working within an FDA-regulated environment is preferred.
• Familiarity with the drug, biologic, or vaccine development process and clinical trial operations is a plus.

Compensation for the Regulatory Operations Associate:

• Hourly rate: $25.96-28.85/hr depending on experience
• Comprehensive Benefits: Medical, Dental, Vision, 401K, and Sick Leave as required by law

Keywords:

Regulatory operations, regulatory affairs support, electronic submissions (eCTD), document management, submission publishing, regulatory compliance, FDA regulations, GCP (Good Clinical Practice), SOP development and maintenance, document quality control, submission readiness, regulatory documentation, records management, audit and inspection support, lifecycle management, regulatory tracking systems, SharePoint, Veeva Vault, submission planning, health authority submissions, cross-functional collaboration, data accuracy, version control, process improvement, workflow management, compliance review, project coordination, database maintenance, attention to detail, communication skills, Microsoft Office Suite, deadline management, clinical research, pharmaceutical development, biologics, vaccine development, regulatory intelligence, change control, and operational support.

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