Nonclinical Regulatory Documentation Specialist at Eurofins

Boston, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Aug, 26

Salary

100000.0

Posted On

22 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Regulatory Documentation, DMPK, Toxicology Reports, Veeva, GLP, FDA Regulations, ICH Guidelines, Microsoft Office, Document Lifecycle Management, Editorial Support, Formatting

Industry

Medical and Diagnostic Laboratories

Description

Company Description 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. 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 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 Expect 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: USD 90000 - USD 100000 - yearly

Responsibilities

Perform quality control and editorial review of nonclinical regulatory documents, including DMPK and Toxicology reports. Manage document lifecycles using Veeva and ensure submission readiness for global regulatory filings.