Senior Regulatory Document Specialist

#LI-Hybrid

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 crossfunctionally to improve documentation clarity, consistency, and compliance effectiveness.

• Minimum Requirement: High School Diploma and 2 years of experience.
• Demonstrated ability to work independently on moderately complex assignments, exercising sound judgment in regulated, qualitydriven 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 crossfunctional 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.

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.