Internship - 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 Program

At Novo Nordisk, interns will have the opportunity to work closely with experienced industry professionals and gain valuable, hands-on, full-time work experience.   For ten weeks, interns will be immersed in the environment of a global pharmaceutical company and contribute to the line of business by providing sustainable and meaningful project work.  Our internship program also includes instructor led trainings, a leadership engagement series, and a guided mentorship program to offer professional and personal development. 

In addition to individual department responsibilities, interns will also participate in the program’s capstone event, the Innovation in Action Case Competition.  Assigned to cross-functional teams, interns will work closely to develop an innovative and comprehensive solution to a business problem currently facing Novo Nordisk.  At the conclusion of the program, teams will present their findings to a board of top Novo Nordisk officials representing the various lines of business.

Program Start: June 2nd, 2025

Program End: August 8th, 2025

Scope of Position

This internship offers a unique opportunity to gain hands-on experience in Regulatory Affairs and labeling within the pharmaceutical industry. The intern will work closely with our Regulatory Affairs Labeling Team to support various labeling projects and ensure compliance with regulatory requirements.

Key Responsibilities include: (1) Assisting in the preparation, review, and submission of labeling documents for regulatory approval, (2) Assisting in filing annual reports, Certificates of Pharmaceutical Products, Puerto Rico Product Registrations, (3) Collaborating with cross-functional teams, including Regulatory Affairs, Quality Assurance, Supply Chain and Marketing, to gather necessary information for labeling updates, (4) Conducting research on Code of Federal Regulations, Food & Drug Administration Labeling Guidance and Patient Labeling Resources, (5) Participating in team meetings and provide updates on labeling projects, and (6) attending Regulatory Affairs forums, label design and system development meetings.

As part of the internship, the intern will be assigned a special project aimed at enhancing the teams labeling processes. This project will involve: Identifying areas for improvement in current labeling procedures, developing and implementing a plan to streamline labeling workflows, and presenting findings and recommendations to the Regulatory Affairs team.

Physical Requirements

• 0% overnight travel required.

Qualifications

• Must be a current student enrolled or recently graduated (graduation date no earlier than May 2025) at/from an accredited college or university pursuing at least a bachelor’s degree.
• A completed or in progress undergraduate degree in Pharmaceutical Sciences, Regulatory Compliance, or a related discipline preferred.
• Strong academic record with a preferred cumulative GPA of 3.0 or higher.
• Conscientious self-starter with good organizational skills, project management skills and attention to detail.
• Ability to balance multiple projects and priorities, must be able to multi-task.
• Strong interpersonal communication and ability to collaborate with teams; must effectively operate independently, across functional lines, and with internal customers.
• Demonstrated personal initiative, self-motivation, flexibility, adaptability and willingness to learn.
• Proficient in Microsoft Office Tools including Word, Excel, PowerPoint, etc.

At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.

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.