Senior Regulatory Document Specialist

Location: Manassas

Overview

Ready to shape the future of science and global health? A global nonprofit that provides trusted biological materials for science and health,
ATCC is hiring a Senior Regulatory Document Specialist to support day-to-day regulatory compliance activities and assigned compliance projects, with excellent opportunities for career growth and professional advancement. This hybrid role in Manassas, VA, creates, reviews, maintains, and communicates governing documentation related to the receipt, handling, production, and distribution of biological materials, as well as applying for, reviewing, and releasing regulatory permits and managing restricted party screening holds regarding sales orders.

The position supports regulatory submissions and audits, interprets documentation requirements, manages regulatory permit releases, and contributes to process improvements while working independently on moderately complex assignments.
We are seeking a Senior Regulatory Document Specialist, ideally with regulatory and compliance experience supporting a regulated or quality-driven environment, who is interested in developing expertise and advancing their career within our growing compliance team. Join ATCC and be part of a team that supports the global scientific community with trusted, authenticated biological materials.

#LI-Hybrid

Responsibilities

• Compliance and Audit Support: Extract, analyze, and summarize documentation for regulatory submissions, audits, and inspections; serve as a liaison supporting auditors and internal stakeholders; apply for, review, and release regulatory permits and manage restricted party screening holds regarding sales orders.
• Regulatory Documentation Management: Maintain, control, archive, and distribute regulated documents and records in alignment with GMP, quality systems, and regulatory requirements, ensuring audit readiness and data integrity.
• Document Authoring and Review: Author, revise, and review SOPs, work instructions, forms, and related documentation to ensure accuracy, completeness, and alignment with internal policies and external regulations.
• Process Governance and Continuous Improvement: Manage document life cycles, approval workflows, revision schedules, and retention practices; partner cross‑functionally to improve documentation clarity, consistency, and compliance effectiveness.

Qualifications

• Minimum Requirement:
  High School Diploma and 2 years of experience.
• Demonstrated ability to work independently on moderately complex assignments, exercising sound judgment in regulated, quality‑driven environments.
• Experience managing controlled documentation within GMP, quality systems, or regulated manufacturing or bioproduction settings.
• Proficiency authoring and maintaining SOPs and related controlled documents supporting compliant operations.
• Strong attention to detail, organizational skills, and understanding of audit readiness and data integrity expectations.
• Ability to interpret regulatory requirements, manage permit applications and restricted party screening processes, and communicate documentation standards to cross‑functional teams.
• Familiarity with electronic document management systems and change control processes preferred.
• Preferred:
  Experience supporting audits, regulatory submissions, permit management, restricted party screening, document approval workflows, revision cycles, or retention practices.

Benefits

The expected salary range for this position is $60,000 to $65,000 annually. Actual compensation will be determined based on experience and qualifications as well as internal equity and alignment with market data. In addition to base salary, this role may be eligible for additional incentive compensation including regular merit increases and the corporate…