Senior Associate, Regulatory Affairs Submission Management

Job title: Senior Associate, Regulatory Affairs Submission Management

About the Role The Senior Associate, Regulatory Affairs Submission Management, handles medium-to-high impact, moderately complex regulatory submission projects with cross-functional teams. They establish and maintain submission content planners and timelines, facilitate tactical submission team meetings, prepare content planners for publishing, interface with publishing vendors, and fulfill Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as a knowledgeable expert in regulatory affairs submission management.

What You'll Do

• Manage medium to high impact submission projects to ensure timely delivery of high-quality dossiers that meet regulatory specifications and can be easily navigated and reviewed by regulatory agencies.
• Act as RA Submissions interface with project teams, providing guidance and communication of established submission processes and standards; contribute input to project scope affecting publishing timelines and deliverables.
• Plan and conduct submission team meetings; coordinate multiple concurrent interrelated activities to meet submission timelines; anticipate obstacles and develop solutions within the team.
• Coordinate submission publishing with offsite publishers; prepare content planners for publishing and work with vendors to resolve publishing issues; may perform in-house publishing tasks.
• Serve as a technical Subject Matter Expert, troubleshooting issues and providing technical systems support; facilitate creation or procurement of submission content deliverables such as cover letters and forms.
• Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance (verification of content, bookmarks, hyperlinks, and tables of contents) and facilitate team reviews.
• Suggest and contribute to process improvements and updates to software or business processes; participate on internal project teams to update business software.
• Demonstrate team leadership and the ability to influence without direct authority; build and maintain positive relationships internally and externally.
• Contribute to the development of optimal business processes and standards within the department to ensure high levels of customer support and quality submissions; contribute to internal process and standards documents related to publishing.
• Note: Some supervision may be required, with oversight from a manager.

What We're Looking For

• Bachelor's degree; four years pharmaceutical or industry-related experience with publishing software tools (e.g., Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight, Adobe Acrobat).
• Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related areas; experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
• Proven leadership skills and presence; ability to influence without direct authority; higher education may compensate for years of experience.
• Certifications such as PMP and RAC are a plus (preferred).

Nice to Have

• PMP and RAC certificates are a plus; additional preference for experience in Regulatory Affairs or broader regulatory operations.

Compensation & Benefits

• The posting indicates a compensation range will be provided based on job grade, with geographic location affecting the actual offer; ranges may be modified in the future.
• We offer a comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• Note: No amount of pay is considered wages or compensation until earned, vested, and determinable.