Senior Regulatory Documentation Specialist - GMP & Submissions

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

Benefits offered by this job

Health & Wellness

401(a) / 403(b) retirement plans

Corporate bonus program

Paid Holidays and PTO

Parental leave

Career development opportunities

Job summary

ATCC in Manassas, VA is hiring a Senior Regulatory Document Specialist to support day-to-day regulatory compliance activities and compliance projects. The role creates, reviews, maintains, and communicates governing documentation for receipt, handling, production, and distribution of biological materials, and manages regulatory permit applications and restricted party screening.

The position requires independent work on moderately complex assignments within GMP/regulated environments, with

Qualifications

• Experience drafting and maintaining controlled documentation in regulated environments.
• Ability to interpret regulatory requirements and support audits and submissions.
• Proficiency creating SOPs and related regulatory documents.

Responsibilities

• Compliance and Audit Support: extract, analyze, and summarize documentation for regulatory submissions, audits, and inspections; liaison with auditors and internal stakeholders; manage permits and screening holds.
• Regulatory Documentation Management: maintain, archive, and distribute regulated documents in GMP and quality systems.
• Document Authoring and Review: write, revise, and review SOPs, forms, and related docs for accuracy and policy alignment.
• Process Governance and Continuous Improvement: manage lifecycles, approvals, revisions, and retention; improve documentation clarity and compliance.

Skills

SOP authoring

Documentation control

Regulatory compliance

Audit readiness

GMP knowledge

Cross-functional communication

Education

High School Diploma

Tools

Electronic document management systems

Job description

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 lifecycles, 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 bonus program.

We Invest in You

• Health & Wellness:
  • Comprehensive medical coverage and company paid Life Insurance, Disability Insurance, AD&D, and paid parental leave
  • Work life balance with Paid Holidays and PTO
  • Fitness and cell phone subsidies, and additional benefits such as legal services, pet insurance and additional supplemental coverage.
  • Employee Assistance Program offering around-the-clock counseling
• Financial security:
  • 401(a) (6% employer contribution) and 403(b) (2% match) retirement plans
  • Exceptional career advancement opportunities, recognition, and rewards
  • Corporate bonus program
• Mission Focused:
  • Non-profit organization supporting critical life science research
  • We give scientists the tools they need to make discoveries that improve and save lives
  • Contribute to community involvement and social responsibility

Join ATCC, where we fuel your success, well-being, and development. We're a mission-focused non-profit Equal Opportunity Employer, celebrating a century of supporting global public health. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Shape the future of science with us.