Nonclinical Regulatory Documentation Specialist

Job Description

We are seeking a detail-oriented and highly organized Nonclinical Regulatory Documentation Specialist to support the quality control, preparation, and management of nonclinical regulatory documents. This role plays a critical part in ensuring submission readiness for DMPK and Toxicology reports, contributing to global regulatory filings in a fast-paced, compliance-driven environment.

Key Responsibilities

• Perform quality control (QC) review of nonclinical documents, including DMPK and Toxicology reports, as well as regulatory submission content (e.g., Module 2 and Module 4).
• Provide editorial and formatting support to ensure documents meet internal standards and global regulatory requirements.
• Prepare and finalize submission-ready Word and PDF documents .
• Support Veeva-based document lifecycle management , including routing, version control, and archival.
• Manage reference-related activities , including literature retrieval, copyright review, and upload into document management systems.
• Identify and resolve documentation issues independently, demonstrating strong judgment and proactive communication.
• Collaborate cross-functionally with scientific and regulatory teams to ensure accuracy, consistency, and compliance.

Qualifications:
Qualifications

• Bachelor’s degree in Life Sciences with 5+ years of relevant experience
• Experience supporting regulatory submissions and/or nonclinical documentation workflows
• Strong knowledge of:
  • Good Laboratory Practices (GLP)
  • FDA regulations and ICH guidelines
  • Nonclinical drug development processes
• Excellent organizational skills with the ability to manage multiple deadlines in a fast-paced environment
• Exceptional attention to detail and strong written communication skills
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Visio)
• Experience with Veeva or other document management systems preferred
• Must be authorized to work in the U.S. without sponsorship

Additional Information

The position is Full Time, Monday through Friday, 8am-5pm. Candidates currently living within a commutable distance of Boston, MA, are encouraged to apply

What to Exp ect in the Hiring Process:

• 10-15 Minute Phone Interview with Regional Recruiter
• 45-60 Minute Virtual Interview with Manager and/or Group Leader

What We Offer:

• Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Yearly goal-based bonus & eligibility for merit-based increases
• Compensation is between $90,000 - $100,000 annually, depending on education and experience

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Compensation:
$90,000-$90,000 per year