Specialist - Regulatory Operations - Submissions job in Princeton
Sign in
Create a candidate account
New Jersey (NJ),
Princeton
Job Code: | 306685-en_US |
Employer: | Novo Nordisk Inc. |
Category: | Regulatory Affairs |
Job Type: | Full Time |
Location | |
Country: | United States |
State: | New Jersey (NJ) |
City: | Princeton |
Post Date: | 05/09/2024 |
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 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 Specialist, Regulatory Operations - Submissions supports the development of submission plans created for regulatory submissions. This individual will be responsible for supporting the preparation, delivery, archiving and tracking of Promotional regulatory submissions (2253, pre clearance, pre submission etc) to the FDA. This individual also supports senior staff with required systems and process maintenance. May also be responsible for supporting the preparation, delivery, archiving and tracking of other regulatory submissions to FDA and Health Canada, however, the primary focus is promotional submissions to the FDA. Relationships Reports to Management in ROI and works cross-functionally with internal departments on Regulatory Affairs related issues. Essential Functions
Physical Requirements 0-10% overnight travel required. Qualifications
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. |
ref: (306685-en_US) 11 days ago
|