The Manager, Regulatory Affairs Submission Management, manages high impact, complex submission
projects involving multiple cross-functional regulatory submission teams. With input from the submission
teams, this individual establishes and maintains submission content planners and associated timelines,
facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with
publishing vendor, and fulfills Submission Management functions on Project Teams in support of
Development, Marketing, and post-marketing regulatory authority applications. The Manager is recognized
as a discipline expert and resource in regulatory affairs submission management.

Responsibilities

• Independently manages high impact (with respect to internal visibility, risk, complexity and criticality)submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
• Acts as primary RA Submissions interface with project teams providing guidance and communication of established submission processes, standards and technical specifications. Plans and negotiates submission project scope, publishing timelines and deliverables.
• Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of complex published submissions within the required timelines. Anticipates obstacles and develop solutions within the team.
• Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks.
• May be a technical Subject Matter Expert troubleshooting issues and providing technical systems support. Facilitates the creation or procurement of submission content deliverables such as cover letters and forms.  Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
• Facilitates team reviews and ensures detailed quality reviews of published output are completed per current standards to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in complex submissions.
• Actively contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions. Creates, implements, and finalizes internal process and standards documents relating to publishing and publishing deliverables.
• Suggests and implements process improvements. May recommend changes to software and business processes to support changes in regulations that support complex submissions May lead or participate on internal project teams to update business software.
• Position accountability/scope: o
  • Minimal supervision required o Receives project assignments from manager but has responsibility for managing own projects.
  • Reviews project progress with manager on a regular basis with direction provided on follow-up.
  • Provides estimates of activities with budgetary impact.
  • Trains, mentors and may supervise the work of less experienced staff.

• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required