Senior Regulatory Writer - Nonclinical

About the Role MMS Holdings Inc. is seeking a Senior Regulatory Writer - Nonclinical to contribute to the development, writing, and management of highly technical nonclinical documents. This full-time, remote role focuses on delivering compliant, scientifically rigorous materials that support regulatory submissions and drug development programs.

What You'll Do

• Develop and write nonclinical documents (Module 2.4/2.6 eCTD submission documents, Investigator’s Brochure, Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs)
• Lead projects independently, guiding structure, content, and messaging to ensure alignment with regulatory guidelines and scientific integrity
• Author from highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro data
• Create mapping plans for placement of nonclinical studies within Module 2.4/2.6 eCTD structures
• Interpret and analyze pharmacokinetics, pharmacology, and toxicology data (e.g., Prism files, bioanalytical reports, clinical pathology, PK/TK evaluation reports)
• Collaborate with cross-functional teams (project management, safety, efficacy, biostatistics, regulatory operations, CMCD)
• Lead others to complete complex projects and ensure sponsor formats and regulatory guidelines are followed
• Communicate effectively in writing and verbally; manage time and projects efficiently
• Participate in regular team meetings and client-facing meetings, and support CRM activities
• Use client systems (SharePoint, Veeva RIM, PleaseReview, EndNote) and templates as required
• Maintain strong understanding of regulatory guidances as they apply to nonclinical submission documents and drug development (ICH, FDA, EMA; GLP, GCP, GMP)

What We're Looking For

• BS degree in pharmacology, toxicology, biology, chemistry or related field with industry experience in regulatory writing, regulatory affairs, laboratory sciences, QA/QC
• Knowledge of GLP, ICH guidelines, and applicable regulatory requirements
• 2+ years of pharmaceutical regulatory nonclinical writing experience
• Strong writing and analytical skills
• Proficiency with MS Office applications; hands-on experience with clinical trials and pharmaceutical development preferred
• Basic understanding of CROs and scientific/nonclinical data terminology and the drug development process