Senior Regulatory Document Specialist
About The Position
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.
Requirements
- 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.
Nice To Haves
- Familiarity with electronic document management systems and change control processes preferred.
- Experience supporting audits, regulatory submissions, permit management, restricted party screening, document approval workflows, revision cycles, or retention practices.
Responsibilities
- 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.
- Maintain, control, archive, and distribute regulated documents and records in alignment with GMP, quality systems, and regulatory requirements, ensuring audit readiness and data integrity.
- Author, revise, and review SOPs, work instructions, forms, and related documentation to ensure accuracy, completeness, and alignment with internal policies and external regulations.
- Manage document lifecycles, approval workflows, revision schedules, and retention practices; partner cross‑functionally to improve documentation clarity, consistency, and compliance effectiveness.
Benefits
- Comprehensive medical coverage
- Company paid Life Insurance
- Disability Insurance
- AD&D
- Paid parental leave
- Paid Holidays
- PTO
- Fitness subsidies
- Cell phone subsidies
- Legal services
- Pet insurance
- Additional supplemental coverage
- Employee Assistance Program
- 401(a) (6% employer contribution) retirement plan
- 403(b) (2% match) retirement plan
- Corporate bonus program
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
