Senior Regulatory Document Specialist (Biotechnology)

Location: Hybrid in Manassas, Virginia, United States

Salary: $60,000–$65,000 annually, with potential incentive compensation through merit increases and a corporate bonus program.

Company

hirify.global is a nonprofit biological resource center and standards organization providing biological materials, model systems, genomic tools, and scientific services for life science research, drug discovery, medicine, and public health.

What you will do

• Create, review, maintain, control, archive, and distribute regulated documents and records.
• Author and revise SOPs, work instructions, forms, and related controlled documentation.
• Support regulatory submissions, audits, inspections, and communications with auditors and internal stakeholders.
• Apply for, review, and release regulatory permits and manage restricted party screening holds for sales orders.
• Manage document lifecycles, approval workflows, revision schedules, retention practices, and audit readiness.
• Partner cross-functionally to improve documentation clarity, consistency, data integrity, and compliance effectiveness.

Requirements

• High school diploma and at least two years of experience.
• Experience managing controlled documentation in GMP, quality systems, regulated manufacturing, or bioproduction environments.
• Proficiency authoring and maintaining SOPs and related controlled documents.
• Ability to work independently on moderately complex assignments in regulated, quality-driven environments.
• Strong attention to detail, organizational skills, and understanding of audit readiness and data integrity.
• Ability to interpret regulatory requirements, manage permit applications and restricted party screening, and communicate documentation standards across functions.

Nice to have

• Familiarity with electronic document management systems and change control processes.
• Experience supporting audits, regulatory submissions, permit management, document approval workflows, revision cycles, or retention practices.

Culture & Benefits

• Nonprofit mission supporting life science research and global public health.
• Medical coverage, company-paid life and disability insurance, AD&D, and paid parental leave.
• Paid holidays, PTO, fitness and cell phone subsidies, legal services, pet insurance, and supplemental coverage.
• Employee Assistance Program with around-the-clock counseling.
• Retirement plans including 401(a) with a 6% employer contribution and 403(b) with a 2% match.
• Career advancement opportunities, recognition programs, and a corporate bonus program.