Regulatory Affairs Manager - Development Strategy

Regulatory Affairs Manager6-Month Assignment (Potential to Extend)Target Start Date: January 5, 2026100% RemotePay: up to $75/hourThe Regulatory Affairs Manager supports global nonclinical and clinical regulatory strategy across multiple programs. The role is responsible for executing delegated regulatory activities, contributing to regulatory documentation, supporting Health Authority interactions, and helping maintain global submissions throughout the product lifecycle.This position works cross-functionally with regulatory, clinical, nonclinical, and operations teams, and plays an important part in ensuring high-quality, compliant, and timely regulatory submissions.Key ResponsibilitiesDevelopment-Stage ProgramsSupport development of nonclinical and clinical regulatory strategies and plans.Assist with planning, documentation, and logistics for Health Authority meetings/interactions.Participate in Study Execution Teams to identify regulatory considerations and communicate them to the RNC Lead.Partner with CROs supporting regulatory submissions and HA interactions for global clinical trials.Draft and coordinate nonclinical/clinical content for global regulatory submissions with oversight from the RNC Lead.Ensure submission content meets quality standards and complies with applicable regulatory guidance.Lead maintenance of INDs/CTAs, including annual reports and ongoing study documentation.Compile materials for HA submission packages (protocols, briefing documents, annual reports, regulatory forms).Align submission timelines with Regulatory Project Management and ensure accurate timeline tracking.Collaborate with Regulatory Operations to finalize documents and review QC'd published outputs.Maintain administrative, nonclinical, and clinical components of INDs, NDAs, and BLAs.Oversee archiving of HA submissions and regulatory correspondence.Commercial-Stage ProgramsLead updates to clinical and nonclinical sections of core dossiers for international marketing applications.Support lifecycle maintenance submissions, including supplements, renewals, and annual reports.Coordinate with international regulatory teams on global filings, agency interactions, and response packages.QualificationsDegree in a life or health science discipline (e.g., biology, chemistry, molecular biology).PhD preferred; Master's/Bachelor's accepted with relevant experience.4 years of regulatory experience, preferably in nonclinical/clinical regulatory affairs.Experience supporting regulatory submissions (INDs/CTAs, supplements, global filings) preferred.Knowledge of global regulatory guidelines and Health Authority expectations.Strong organizational skills with the ability to manage timelines and multiple deliverables.Excellent communication skills and ability to work cross-functionally.Company DescriptionThe TPS Group, www.tpsmithgroup.com, is a Certified Woman and Disabled Owned Diverse recruiting and staffing firm that is a trusted recruiting partner to top companies.

Salary : $70 - $75