Job Description

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. 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 Regulatory Ops Labeling Manager is a dynamic and experienced manager to oversee and lead critical tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects guided by company content of labeling, FDA Patient Labeling Resources, FDA Label Negotiations and Industry trends. This requires labeling verification to include the review across the product family of physician and patient leaflets, carton and container labels as well as device labels. The ideal candidate will collaborate 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), engaging with key company personnel within Novo Nordisk Inc., US (NNI) and Novo Nordisk A/S (NN) to drive successful project outcomes for assigned projects. Develops and maintains positive working relationships with company stakeholders, fostering effective collaboration with Regulatory Affairs (RA), Supply Chain, and HQ colleagues to ensure labeling compliance and accomplish company goals.

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 successful on-time launch of product labeling per company launch readiness timelines
  • Ensures 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 a subject matter expert in all labeling tools (SPL, TVT, Veeva Vault, Esko, Acrobat, etc.) coordinating technical support needs with internal IT groups
  • Utilizing FDA portals and tools to include WebTrader, CDER NexGen, FURLS, SPL Help Desk, FDALabel, Drugs@FDA and coordinating with agencies to resolve any issues
• Regulatory Support:
  • Act as a resource for colleagues, providing guidance, training, and mentorship, while 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 to work effectively with cross-functional teams and key company personnel
  • Strong problem-solving abilities with a 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 be substituted for degree, when appropriate and is dependent on the requirements of the position
• A minimum of 6 years progressively responsible, relevant experience, with a concentration in labeling development and lifecycle management
• An experienced professional having a wide range of patient label development and final printed label knowledge to include a complete understanding of regulatory labeling operations roles and responsibilities
• Demonstrates 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; proactively identify risks; develop risk mitigation strategies; communicate project team decisions and project status
• Proficiency with Microsoft Office, Veeva Vault(s), A4L, ALiCE, and TVT
• Excellent verbal and written communication and skills
• Ability to work independently and collaboratively, as required, in a fast-paced, team environment consisting of local and global team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

The base compensation range for this position is $99,600 to $184,200. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.