Manager, Regulatory Affairs, Operations

Position Summary

The Manager, Regulatory Operations supports the planning, preparation, publishing, submission, tracking, and lifecycle management of global regulatory submissions. The role partners with Regulatory Affairs, cross-functional contributors, Information Technology, Quality, and external vendors to ensure submission content and regulatory information are complete, accurate, timely, inspection-ready, and compliant with applicable health authority requirements and internal procedures. The Manager also supports effective use and continuous improvement of Regulatory Information Management (RIM) capabilities, including document management, submission planning and tracking, registrations, health authority correspondence, reporting, and data quality oversight.

Primary Responsibilities

• Plan, prepare, publish, quality-check, dispatch, and track electronic regulatory submissions in accordance with global regulatory requirements, internal standards, and committed timelines
• Coordinate submission activities with Regulatory Affairs leads, authors, reviewers, vendors, and other stakeholders; proactively identify risks, dependencies, and timeline impacts
• Ensure submission-ready documents meet applicable formatting, technical, metadata, and lifecycle requirements, including eCTD and other regional electronic submission standards
• Support the operation and administration of the RIM ecosystem, which may include electronic document management, submissions, submissions archive, registrations, regulatory activities, commitments, and health authority correspondence
• Monitor RIM data for completeness, accuracy, consistency, and timeliness from regulatory planning through submission and health authority interaction; coordinate remediation with data owners
• Ensure required metadata are entered and maintained for regulatory objects, documents, activities, submissions, applications, registrations, and correspondence to support downstream processes, reporting, and traceability
• Partner with stakeholders to define, document, and improve regulatory processes, work instructions, job aids, controlled procedures, and data standards
• Provide role-based training, coaching, and technical support for regulatory systems, submission processes, document standards, and RIM data practices
• Support periodic releases, upgrades, and enhancements to validated regulatory systems
• Contribute to inspection readiness by ensuring regulatory records, submission archives, system documentation, and operational evidence are complete, accessible, and maintained in accordance with procedures
• Stay current on evolving global regulations, guidance, industry standards, and best practices affecting regulatory submissions, document management, and RIM
• Perform other duties and special projects as assigned

Education/Experience/Skills

• Bachelor's degree in regulatory affairs, life sciences, information management, or a related field. An equivalent combination of relevant education and experience may be considered
• Targeting 5 years of progressively responsible experience in Regulatory Operations, regulatory submissions, regulatory systems, document management, and/or Regulatory Information Management in the biopharmaceutical or life sciences industry
• Hands-on experience supporting electronic regulatory submissions and working with validated regulatory technology platforms; experience with a RIM suite is strongly preferred
• Experience with global submission requirements, eCTD, regulatory document standards, metadata, records management, and submission lifecycle management
• Experience supporting system changes, testing, validation or assurance activities, training, metrics, and process improvement
• Strong understanding of Regulatory Operations business processes and the functional document types that comprise global regulatory submissions, including clinical, nonclinical, quality, labeling, and administrative content
• Working knowledge of RIM data models and processes, including regulatory activities, applications, submissions, registrations, commitments, correspondence, document metadata, and reporting
• Excellent written and verbal communication skills, including the ability to train users, facilitate discussions, and influence without direct authority
• Demonstrated project management, organization, prioritization, and problem-solving skills in a deadline-driven environment with changing priorities
• High attention to detail, sound judgment, accountability, integrity, and a strong commitment to quality and compliance
• Ability to work independently with moderate guidance while collaborating effectively across functions and with external partners
• Proficiency with Microsoft Office applications and PDF tools; experience with regulatory publishing and RIM platforms is preferred
• Willingness and ability to travel domestically and internationally as needed