Regulatory Affairs Specialist - On-site

Responsibilities

• Prepare, publish, perform quality control, and deliver paper and electronic components of regulatory submissions, including initial large marketing authorization applications and electronic common technical documents (eCTD).
• Produce submissions using electronic publishing tools in compliance with document management standards and applicable regulatory/quality requirements.
• Manage activities related to enterprise-wide regulatory management systems, including systems coordination, user support, and data maintenance.
• Develop and deliver training for colleagues on regulatory systems, tools, and related processes.
• Contribute to the development, implementation, and continuous improvement of regulatory systems and processes, including input to system design and enhancements.
• Prepare, submit, track, index, and archive paper and electronic submissions such as supplements, amendments, annual reports, general correspondence, adverse event reports, and promotional material filings.
• Collaborate cross-functionally (e.g., with R&D, Quality, Clinical, Marketing) to collect required information, resolve issues, and provide clear regulatory status updates, including report-outs to leadership.

Qualifications

• Baccalaureate degree
• Minimum of 2 years of relevant experience in a regulated industry
• Experience with regulatory or other complex data systems, including data entry, reporting, and troubleshooting
• Demonstrated ability to analyze data and metrics to inform decision-making and process improvements
• Strong cross-functional collaboration skills and experience working with diverse stakeholder groups
• Experience preparing or contributing to regulatory submissions (e.g., eCTD, marketing applications, annual reports, amendments, or adverse event reporting)
• Strong attention to detail, organizational skills, and ability to manage multiple projects and deadlines
• Effective written and verbal communication skills, including clear report-outs to leadership