Description

• 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 Submission Management interface with project teams providing guidance and communication of established submission processes and standards. 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
• Facilitates the creation or procurement of submission content deliverables such as cover letters and forms
• Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance’s including verification of content, bookmarks, hypertext links and tables of content in complex submissions. Facilitates team reviews.
• 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.
• Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
• Position accountability/scope:
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Qualifications

• Pharmaceutical or industry related experience
• Experience working in a complex and matrix environment
• Strong communication skills both oral and written
• Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
• Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
• Proven leadership skills and presence