Senior Regulatory Documentation Specialist

ATCC; Innovation (VA); Hybrid; USD 60,000 - 65,000; Full time

Benefits offered by this job

Health Insurance (company paid)

Life Insurance (company paid)

Disability Insurance (company paid)

AD&D (company paid)

Paid parental leave

Paid holidays

PTO

401(a) retirement plan

403(b) retirement plan

Corporate bonus program

Employee Assistance Program

Job summary

ATCC, a global nonprofit, seeks a Senior Regulatory Document Specialist in Manassas, VA. The role involves creating, reviewing, and maintaining governing documents for regulatory permits, submissions, and restricted party screening, with support for audits and process improvements.

It operates in a hybrid setting within Legal & Compliance. The position emphasizes independent work on moderately complex tasks, SOP authoring, and cross-functional collaboration to ensure compliance and data

Qualifications

• High School Diploma and 2 years of experience required.
• Ability to work independently on moderately complex assignments in regulated environments.
• Experience managing controlled documentation within GMP/quality systems or regulated settings.
• Proficiency authoring and maintaining SOPs and related controlled documents.
• Strong attention to detail and audit readiness understanding.

Responsibilities

• Compliance and Audit Support: prepare docs for regulatory submissions, audits, inspections; assist auditors and stakeholders; manage permits and screening holds.
• Regulatory Documentation Management: control, archive, distribute regulated docs ensuring audit readiness and data integrity.
• Document Authoring and Review: write, revise SOPs, forms, and related materials for accuracy and compliance.
• Process Governance and Continuous Improvement: manage lifecycles, approvals, revision schedules, retention; improve clarity and compliance.

Skills

Attention to detail

Organizational skills

Independent worker

Regulatory interpretation

Cross-functional collaboration

Education

High School Diploma

Tools

Document management systems

Job description

ATCC, a global nonprofit, seeks a Senior Regulatory Document Specialist in Manassas, VA. The role involves creating, reviewing, and maintaining governing documents for regulatory permits, submissions, and restricted party screening, with support for audits and process improvements.

It operates in a hybrid setting within Legal & Compliance. The position emphasizes independent work on moderately complex tasks, SOP authoring, and cross-functional collaboration to ensure compliance and data