Specialist - Regulatory Affairs - Labeling

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 Labeling Specialist supports the development of labeling activities for all regulatory submissions. This individual collaborates cross-functionally and applies skills and knowledge of drug development and how it relates to labeling operations and requirements to manage the execution of final packaging materials for product launch. This individual also supports the systems and processes by which regulatory labeling items are created, approved submitted and maintained for use. The Labeling Specialist is also responsible for maintaining product and establishment registrations (drug/establishment listings) and submission to FDA databases. This individual acts as the Subject Mater Expert (SME) for electronic reports that are FDA compliant and with the required format (e.g., Structured Product Labeling (SPL), Lot Distribution Data (LDD), etc.) and that is in alignment with the regulatory strategy. This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling management in Regulatory Operations and Innovation. Develop and maintain positive rapport and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs, CMR, Supply Chain, and HQ colleagues regarding labeling compliance to accomplish company goals. External relationships may include interaction with FDA personnel, IT vendors and HQ colleagues regarding assigned projects and roles. Essential Functions Participates on cross-functional teams focused on the planning and execution of regulatory labeling operations. This includes anticipating labeling obstacles, identifying emerging issues and proactively developing solutions May participate in FDA submission planning meetings to ensure clear communication of the project plan, actions items, risks, and decisions to the team as it relates to labeling operation processes Ensures that all regulatory labeling items and information is appropriately tracked, archived, searchable and accessible Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.) Works directly with Regulatory Project Mangers to prepare labeling items consistent with content project plans Participates locally and globally in initiatives focused on the improvement of regulatory labeling processes and tools (LIFT, Veeva Vaults, TVT, ALiCE, novoGlow, etc.). This includes contributing to new regulatory processes and providing training support as appropriate Contributes to the development of SOPs, Work Instructions (WIs) and training materials required to support regulatory labeling-related activities. Updates internal processes to ensure compliance with health authority requirements and expectation Physical Requirements 0-10% overnight travel required. Qualifications A Bachelors degree required and minimum 4 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and education required with a concentration in labeling development and maintenance 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 participate in process/system improvements related to labeling and product/establishment registrations (LIFT, Veeva Vaults RIM, Registrations, and SPL) May be responsible for managing projects, processes, or programs with manager oversight Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance’s/specifications/regulations Proficiency with Microsoft Office, Veeva Vault, TVT, ALiCE, LIFT, novoGlow and other labeling systems Excellent verbal and written communication and skills Ability to work independently and collaboratively, in a fast-paced environment consisting of local and global team members Willing to hire at a higher level commensurate with experience. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.