Specialist - Regulatory Affairs - Labeling
- Employer
- Novo Nordisk
- Location
- Plainsboro, NJ
- Start date
- Oct 25, 2024
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- Discipline
- Clinical, Clinical Medicine, Manufacturing & Production
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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
Physical Requirements
0-10% overnight travel required.
Qualifications
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.
Company
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.
Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.
CONNECT
- Website
- https://www.novonordisk-us.com/
- Phone
- 617-612-6200
- Location
-
75 Hayden Avenue
Lexington
MA
02421
United States
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