Publishing Associate Manager - Regulatory Operations

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 Associate Manager, Regulatory Operations - Submissions supports the development of submission plans created for regulatory submissions. This individual collaborates cross-functionally and applies project management skills and knowledge of drug development and how it relates to regulatory dossier practices and requirements to manage the execution of submissions. This individual also supports the systems and processes by which regulatory documentation is created, approved, submitted, maintained for use, and made readily searchable and accessible.

The Associate Manager, Regulatory Operations Submissions is also responsible for tracking the progress of all components of a regulatory submission dossier. This individual acts as Subject Matter Expert (SME) for producing a dossier that is compliant with the required format (i.e., eCTD, paper, etc.) and that is in alignment with the submission strategy.

The individual works cross-functionally with internal departments on Regulatory Affairs related issues.

 

Relationships

This person will report to management in Regulatory Operations and Innovation.

Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments as needed.

 

Essential Functions

• 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
• 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 little management oversight, independently manage 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)
• Works directly with Regulatory Project Mangers to develop submission content project plans
• Works directly with publishing colleagues, to ensure an accurate and quality assembly of submission dossiers
• With little management oversight, 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 little management oversight, independently and actively manage and/or participate in projects related to system enhancements, product transfers and/or other Regulatory needs
• With little management oversight, may contribute 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 and equivalent experience may be substituted for degree
• A minimum of 6 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 sta