Senior Manager Regulatory Affairs

Key Responsibilities Provide operational leadership supporting global regulatory submissions from planning through archival Serve as the business lead for Regulatory Information Management and Veeva RIM Basics Partner with cross-functional stakeholders to implement standardized document lifecycle management Support the transition to an internal Regulatory Operations publishing model Develop and maintain inspection-ready regulatory information supporting U.S. and global regulatory submissions Partner with the Director of Regulatory Operations to modernize Regulatory Operations through technology and automation Partner closely with Regulatory Affairs, Medical Writing, Clinical Development, CMC, Quality, and external partners to ensure high-quality, compliant, and timely regulatory submissions Requirements Bachelor's degree in Life Sciences or related discipline, or equivalent combination of education and relevant Regulatory Operations experience Approximately 6-10 years of Regulatory Operations experience within the biotechnology or pharmaceutical industry Extensive experience supporting FDA electronic submissions Strong knowledge of eCTD publishing and submission lifecycle management Experience with Veeva Vault RIM or Veeva RIM Basics Experience supporting regulatory information management systems Experience supporting global submissions, including CTAs and Health Authority interactions Experience training end users on regulatory systems Experience developing Regulatory Operations processes and SOPs Strong project management and organizational skills Excellent communication and collaboration skills Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovative use of AI is a strong plus Able to attend in-person meetings Core Competencies Demonstrates expertise in Regulatory Operations with a focus on global regulatory submissions, eCTD publishing, and regulatory information management. Proven ability to lead cross-functional teams and implement technology solutions to enhance operational efficiency. Highest-signal resume keywords Regulatory Operations Experience ECTD Publishing Veeva Vault RIM FDA Electronic Submissions Project Management ATS Optimization Keywords Hard Skills Regulatory Information Management Document Lifecycle Management Regulatory Submissions SOP Development Inspection-Ready Documentation Global Submissions CTAs Health Authority Interactions AI Tools Utilization Training End Users Soft Skills Communication Skills Collaboration Skills Organizational Skills Leadership Skills Project Management Skills Industry Keywords Biotechnology Pharmaceutical Industry Regulatory Affairs Clinical Development Quality Tools & Technologies Veeva RIM Basics Regulatory Information Management Systems AI Tools #J-18808-Ljbffr