Regulatory Operations Associate

Piper Companies; Bethesda (MD); Hybrid; USD 36,000 - 40,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K

Sick leave

Job summary

Piper Companies in Bethesda, MD is seeking a Regulatory Operations Associate for a hybrid role. The position joins a mission-driven organization focused on advancing healthcare innovation through research, technical, and operational solutions.

You will support regulatory filing processes, maintain filing systems, draft and format documents, develop SOPs and templates, monitor activities, and provide administrative support for regulatory affairs.

Qualifications

• Bachelor's Degree required.
• 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 prioritize competing projects and deadlines.
• Knowledge of GCP guidelines and/or experience in an FDA-regulated environment preferred.
• Familiarity with drug, biologic, or vaccine development process and clinical trial operations is a plus.

Responsibilities

• Prepare and support regulatory filing documentation, ensuring timely distribution to stakeholders.
• Maintain electronic and hard-copy filing systems to support regulatory compliance and audit readiness.
• Draft, revise, format, and distribute documents using templates, procedures, and work instructions.
• Create and maintain process improvement tools, including templates, SOPs, work instructions, and checklists.
• 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.

Skills

Organizational skills

Communication skills

Regulatory submissions

Prioritization

GCP knowledge

FDA-regulated familiarity

Education

Bachelor's Degree

Tools

eCTD platforms

SharePoint

Veeva Vault

Job description

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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