Senior Regulatory Documentation Lead (Hybrid)

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

Benefits offered by this job

Health insurance

401(a) retirement plan

403(b) matching contributions

Paid holidays

PTO

Life Insurance (company paid)

Disability Insurance

Parental leave

Employee Assistance Program

Corporate bonus program

Job summary

ATCC in Manassas, VA is seeking a Senior Regulatory Document Specialist to support regulatory compliance activities and manage documentation related to the receipt, handling, production, and distribution of biological materials.

This hybrid role involves preparing regulatory permits, reviewing submissions, maintaining audit readiness, and collaborating with cross-functional teams. The position offers professional growth within a mission-driven nonprofit focused on global health.

Qualifications

• Minimum requirement: High School Diploma and 2 years of experience.
• Experience in regulated, quality-driven environments.
• Proficiency authoring and maintaining SOPs and controlled documents.
• Familiarity with GMP, quality systems, or regulated manufacturing.

Responsibilities

• Extract, analyze, and summarize documentation for regulatory submissions, audits, and inspections; support auditors and internal stakeholders; manage permits and restricted party screening for sales orders.
• Maintain, archive, and distribute regulated documents and records in line with GMP and regulatory requirements; ensure audit readiness and data integrity.
• Author, revise, and review SOPs, work instructions, forms, and related documentation for accuracy and compliance.
• Manage document lifecycles, approvals, revision schedules, and retention; collaborate cross-functionally to improve clarity and compliance.

Skills

Regulatory compliance

Documentation management

SOP writing

Audit support

Attention to detail

Cross-functional collaboration

Permit management

Electronic document management

Change control

Education

High School Diploma

Job description

ATCC in Manassas, VA is seeking a Senior Regulatory Document Specialist to support regulatory compliance activities and manage documentation related to the receipt, handling, production, and distribution of biological materials.

This hybrid role involves preparing regulatory permits, reviewing submissions, maintaining audit readiness, and collaborating with cross-functional teams. The position offers professional growth within a mission-driven nonprofit focused on global health.