Regulatory Operations Labeling Manager

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 healthcare 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, finding better and more innovative ways to improve their quality of life. The Position The Regulatory Ops Labeling Manager is a dynamic and experienced manager who oversees and leads critical tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects. This role is guided by company labeling content, FDA Patient Labeling Resources, FDA Label Negotiations and industry trends. Responsibilities include labeling verification across the product family of physician and patient leaflets, carton and container labels, and device labels. The ideal candidate collaborates with cross‑functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling Projects and Planning Coordinators (LPPC), Graphic Designers, Marketing and Supply Chain. Relationships Reports to labeling management in Regulatory Operations (RO) and engages with key personnel within Novo Nordisk Inc., US (NNI) and Novo Nordisk A/S (NN) to drive successful project outcomes. Builds and maintains positive working relationships with company stakeholders, fostering effective collaboration with Regulatory Affairs, Supply Chain and HQ colleagues to ensure labeling compliance. Essential Functions Label Development Represent RO Labeling during NNI – Local Labeling Committee (LLC) and HQ – Product Labeling Council meetings and communications, ensuring accurate reconciliation and incorporation of comments into draft labels in collaboration with responsible TA personnel. Drive the Final Printed Labeling review and approval process based on final approved labeling content from FDA, collaborating with TA, LPPC and Graphic Designers to ensure on‑time launch of product labeling per company launch readiness timelines. Ensure additional filing requirements are completed for approved content of labeling to include SPL drug listing, FDA 2253s and Puerto Rico registrations. Labeling Tools Serve as subject‑matter expert in all labeling tools (SPL, TVT, Veeva Vault, Esko, Acrobat, etc.), coordinating technical support needs with internal IT groups. Utilize FDA portals and tools to include WebTrader, CDER NexGen, FURLS, SPL Help Desk, FDALabel, View email address on click.appcast.io and coordinate with agencies to resolve any issues. Regulatory Support Provide guidance, training, and mentorship to colleagues, contributing to the development of new concepts, standards and techniques in labeling operations. Participate in cross‑functional teams locally and globally, demonstrating good judgment in troubleshooting to resolve problems of moderate scope and complexity. Competence in Lot Distribution Data Reports, CARES Act Distribution Reporting, SPL Blanket No‑Change Certification, FDA Establishment Registrations, FDA Annual Reports, FDA PBRER, Certificate of Pharmaceutical Products, and PRDOH Puerto Rico Registrations. Actively participate in industry meetings and conferences to stay abreast of regulatory developments and industry trends. Skills and Experience Proficiency with 21 CFR Labeling, Physician Labeling Rule (PLR), Selected Requirements of Prescribing Information, FDA Patient Labeling Resources, Medication Guides, Instructions for Use, National Drug Codes, industry‑standard labeling trends, DUNS, and FEI Registrations. Excellent communication, collaboration and interpersonal skills for effective cross‑functional teamwork. Strong problem‑solving abilities with keen attention to detail and adherence to federal requirements and best practices. Proven ability to independently manage labeling processes, prioritize tasks and drive successful outcomes. Physical Requirements 0‑10% overnight travel required. Qualifications A Bachelor's degree required; relevant experience may substitute for degree, depending on position requirements. Minimum of six years progressively responsible, relevant experience focused on labeling development and lifecycle management. Advanced knowledge of patient label development and final printed label processes, including regulatory labeling operations roles and responsibilities. Full knowledge of industry practices and standards related to labeling, product listings and establishment registrations. Demonstrated ability to work cross‑functionally to develop project plans, identify risks, develop mitigation strategies and communicate status. Proficiency with Microsoft Office, Veeva Vault(s), A4L, ALiCE and TVT. Excellent verbal and written communication skills. Ability to work independently and collaborate in a fast‑paced, team environment with local and global members. Analytical thinker with strong problem‑solving skills and ability to adapt to changing priorities and deadlines. Excellent planning, organization and time‑management skills, including ability to support and prioritize multiple projects. Compensation and Benefits The base salary range for this position is $99,600 to $184,200 . Base compensation is determined based on a number of factors and the role is eligible for company bonus based on individual and company performance. Novo Nordisk offers long‑term incentive compensation and/or company vehicles depending on position level. Employees are eligible to participate in company benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. Time off is provided pursuant to the company sick time, flexible vacation and parental leave policies. Equity and Equality Statement We commit to an inclusive recruitment process and equality of opportunity for all applicants. 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. Special Assistance for Applications If you are interested in applying and need special assistance or accommodation please call View phone number on click.appcast.io. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. #J-18808-Ljbffr Novo Nordisk