Specialist - Regulatory Affairs at Novo Nordisk

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

Provide proactive support and technical assistance to more experienced regulatory personnel. Identify issues and inform appropriate individuals. Ability to work with less supervision than Associate. Take initiative to assist with overflow in other areas as needed.

Relationships

Reports to a Manager, Senior Manager, Associate Director or Director. Works with personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs. Has a positive approach to work projects and maintains constructive and positive interactions with colleagues.

Essential Functions

• Therapeutic Area:
• Assist Manager/Director in review of labeling for marketed products and new products as assigned
• Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guidelines, and proactively provides guidance to ROI staff as needed during assembly of regulatory submissions
• Draft more complex correspondence
• Draft ROCs for more complex contacts
• Prepare routine correspondence
• Provide proactive support and technical assistance during preparation and review of regulatory documents
• As assigned, participate in project teams
• Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents
• Assume additional responsibilities as applicable
• Complete internet searches
• Proactively manage the scope of project responsibilities, identify and compose draft correspondence relevant to projects on own initiative, such as letters of response, transmittal and memoranda where applicable. Use and contribute to development of templated correspondence as appropriate, ensuring that all new information is correct
• Proactively seek and find information/potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward
• Provide proactive support in managing project
• Take the initiative to assist with overflow in other areas as needed
• Advise stakeholders of submission completion
• Compile applications and prepare for sign-off (INDs/NDAs/BLAs/510ks, IND amendments & Annual Progress Reports, NDA Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA communications, among others as assigned), assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisors’ requirements and guidance
• Coordinate review of documents and follows up to resolve issues
• Obtain documents/information for regulatory submissions from various functional areas and checks for errors, missing information, legibility, translations, etc.
• Proactively coordinate document submission
• Proactively identify issues and inform appropriate individuals
• Review information from local & NNAS contributing departments and provide comments to assure that documents are accurate and complete and comply with FDA regulations
• Works with manager to gather internal intelligence including tracking and maintaining the Submissions Plan update. Consolidates research and gathers Novo Nordisk opinions/position (e.g. FDA draft guidances, proposed rules). Works with manager to compose letters incorporating NN position on external regulatory initiatives
• Works with Group Manager to maintain surveillance of regulatory environment and competitor development
• Evaluates submission information for input into Regulatory Information Management System (RIMS) within required timelines
• Responsible for maintenance reports notification for all projects/products Quarterly and Annual Safety Updates. Works with Labeling group to ensure timely completion of labeling tasks and assignments
• Participates in department forum meetings e.g. CMC, PRB, and ensures that proper minutes from these meetings are available in the database. Assists with overflow in other areas as needed and handle other duties and/or special projects as assigned by Regulatory Management