Specialist - Regulatory Operations Submissions

Role Summary

The Specialist, Regulatory Operations - Submissions supports the development of submission plans created for regulatory submissions. This individual will be responsible for supporting the preparation, delivery, archiving and tracking of regulatory submissions to FDA and Health Canada. This individual also supports senior staff with required systems and process maintenance. Responsible for supporting the preparation, delivery, archiving and tracking of regulatory submissions to FDA and Health Canada.

Responsibilities

• With direction from management participates on cross-functional teams focused on the planning and execution of regulatory submissions. This includes anticipating regulatory submission obstacles, identifying emerging issues and proactively developing solutions.
• With direction from management participates in FDA and HC submission planning meetings to ensure clear communication of the project plan, actions items, risks, and decisions to the team.
• With direction from management, manages multiple regulatory submission projects, including the development of submission content plans.
• Ensures that all regulatory content and information is appropriately tracked, archived, searchable and accessible.
• Enters and tracks project and submission data in Regulatory Information Management system (Vault RIM).
• With direction from management works directly with Regulatory Project Managers to develop submission content project plans.
• With direction from management works with publishing colleagues, to ensure an accurate and quality assembly of submission dossiers.
• With direction from management participates locally and globally in initiatives focused on the improvement of regulatory submission management processes and tools (Veeva Vaults RIM, Registrations, Publishing and AdPromoMats). This includes developing and contributing to new regulatory processes and providing training support as appropriate.
• With direction from management contributes to the development of SOPs, Work Instructions (WIs) and training materials required to support regulatory submission-related activities. Updates internal processes to ensure compliance with health requirements and expectations.

Qualifications

• A Bachelor's Degree Required; relevant experience may be substituted for degree, when appropriate
• A minimum of 4 years progressively responsible, relevant experience, with a concentration in document management and eCTD publishing
• Demonstrated ability to work cross-functionally to develop project plans; proactively identify risks; develop risk mitigation strategies; communicate project team decisions and project status.
• Demonstrated ability and knowledge to define, and lead the implementation of, process/system improvements related to regulatory submissions (Veeva Vaults RIM, Registrations, Publishing and AdPromoMats).
• May Provide guidance and training to less experienced professionals or support staff. Demonstrates leadership qualities; may act as project leader in the development and implementation of processes and programs. May be responsible for managing projects, processes, or programs with own manager oversight
• Full knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance‚Äôs/specifications/regulations
• Proficiency with Microsoft Office, Veeva Vault(s), CSC Toolbox
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, team environment consisting of local and global team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Skills

• Regulatory submissions planning
• eCTD publishing
• Regulatory Information Management (RIM) systems
• Project management
• Cross-functional collaboration
• Process improvement

Education

• Bachelor's Degree (or equivalent experience as noted in Qualifications)