About this role
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. Bachelor’s degree in Life Sciences with 5+ years of relevant experienceExperience supporting regulatory submissions and/or nonclinical documentation workflowsStrong knowledge of:Good Laboratory Practices (GLP)FDA regulations and ICH guidelinesNonclinical drug development processesExcellent organizational skills with the ability to manage multiple deadlines in a fast-paced environmentExceptional attention to detail and strong written communication skillsProficiency with Microsoft Office (Word, Excel, PowerPoint, Visio)Experience with Veeva or other document management systems preferredMust be authorized to work in the U.S. without sponsorship 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 Recruiter45-60 Minute Virtual Interview with Manager and/or Group LeaderWhat We Offer:
Excellent full-time benefits, including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysYearly goal-based bonus & eligibility for merit-based increasesCompensation 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.