Specialist - Regulatory Operations - Submissions

About the Department                                                                                                                                               

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

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 Promotional regulatory submissions (2253, pre clearance, pre submission etc) to the FDA.  This individual also supports senior staff with required systems and process maintenance.  May also be responsible for supporting the preparation, delivery, archiving and tracking of other regulatory submissions to FDA and Health Canada, however, the primary focus is promotional submissions to the FDA.

 

Relationships

Reports to Management in ROI and works cross-functionally with internal departments on Regulatory Affairs related issues.

 

Essential Functions

• 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 authority requirements and expectations

 

Physical Requirements

0-10% overnight travel required.

 

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’s/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