Nonclinical Regulatory Docs Specialist – DMPK & GLP

Nonclinical Regulatory Documentation Specialist

At Eurofins Professional Scientific Services (PSS), the work we do matters—and so do our employees. We are committed to supporting your professional growth while helping you build a meaningful career in the biopharmaceutical industry. Our teams are collaborative, supportive, and focused on delivering high-quality scientific services while maintaining work-life balance and offering a competitive benefits package.

Eurofins Scientific is a global leader in life sciences, providing a wide range of analytical testing services across pharmaceutical, environmental, food, and consumer product industries. Our work helps ensure safety, quality, and sustainability worldwide.

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.

• 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.

• 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).
• Strong knowledge of FDA regulations and ICH guidelines.
• Strong knowledge of 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.

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

• 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 and eligibility for merit‑based increases.
• Compensation between $90,000 and $100,000 annually, depending on education and experience.

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