Senior Regulatory Document Specialist

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

Benefits offered by this job

Health coverage

401(a) retirement plan

403(b) matching

Corporate bonus program

Paid holidays and PTO

Job summary

ATCC is seeking a Senior Regulatory Document Specialist in Manassas, VA, offering a hybrid work model. The role focuses on creating, reviewing, and managing governing documentation for biological materials, permits, and restricted-party screening, while supporting regulatory submissions and audits.

Qualifications include a high school diploma with 2 years in regulated environments, the ability to work independently, and strong SOP/document control experience.

Qualifications

• High School Diploma and 2 years of experience in regulated environments.
• Ability to work independently on moderately complex assignments in quality-driven settings.
• Experience drafting and maintaining SOPs and controlled documents.

Responsibilities

• Extract, analyze, and summarize documents for regulatory submissions, audits, and inspections.
• Maintain and control regulated documents to ensure audit readiness and data integrity.
• Author and revise SOPs, work instructions, and related documentation.
• Manage document lifecycles, revision schedules, and cross-functional approvals.

Skills

Independent work

Attention to detail

Audit readiness

Document management

Education

High School Diploma

Tools

Electronic document management systems

Job description

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.

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.