In addition to Base Salary, Annual Bonus and Long Term Incentive Cash Bonus offered.
Telecommuting is allowed.
Employer will assist with relocation costs.
Internal Number: 229842
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 Food & Drug Administration (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?
Oversee all assigned projects/products/processes. Assist the Director/Senior Director in assuring Novo Nordisk compliance with internal Standard Operating Procedures (SOPs) and Federal and State regulations, including compilation and submission of any required documents to regulatory agencies. Act as liaison with FDA for assigned projects. Position can be based remote with quarterly travel to our NJ office.
Report to the Senior Director Regulatory Affairs. Interact with key company personnel both within and outside of Novo Nordisk-US as related to assigned projects. Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments in support of initiatives and to accomplish company goals. FDA liaison for designated projects or as requested by supervisor.
Act as liaison with Novo Nordisk Inc (NNI) and Novo Nordisk AS (NNAS) departments for preparation of documentation necessary for submission of applications
Approve specified regulatory submissions
Assist senior Regulatory Affairs personnel in assuring compliance
Coordinate and supervise the development of regulatory strategies for new or modified pharmaceutical products and for 510(k) devices under development or license for assigned projects
Facilitate and organize the compilation of applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications
FDA liaison on key matters
Identify the need for and provide input into development of systems for assigned projects for the efficient operation of the department
Lead FDA meetings
Lead major label negotiations
Manage complex projects
May act as FDA liaison for all project issues
May act as Global Regulatory Team (GRT) member
Participate in and/or coordinate all negotiations and interacts with FDA personnel as assigned
Provide information and training for NNAS in areas of IND, NDA, and 501(k) processes. Disseminate information on proposed and new FDA regulations and guidelines for assigned products/projects
Provide input into development of regulatory and quality systems
Provide input into development of Standard Operating Procedures (SOPs) for the efficient operation of the department and inter-department activities
Provide training to the regulatory staff and Sales Reps as needed
Responsible for development of regulatory submission strategies
Review data from contributing departments (including NNAS) and provide comments to assure accurate and complete documents for inclusion in these applications
Submit all types of applications to FDA
Supervise and advise staff members
Supervise and coordinate all regulatory activities relating to regulatory compliance for assigned marketed and investigational products
Supervise and coordinate the planning of FDA submissions for assigned products/projects to ensure most efficient use of resources
Supervise the review and sign-off on all labeling for marketed products prior to use for assigned products/projects
A Bachelors required/Advance degree preferred; Life Science degree preferred; expertise in project area/s preferred
A minimum of 8 years total pharmaceutical/related industry experience required
Excellent verbal and written communication skills essential
Experience and knowledge of the relevant current requirements of FDA required
For global projects, prior interaction or exposure with other key regulatory authorities e.g. EMEA, EU national authorities, PMDA
Good interpersonal skills; ability to interact with staff on all levels???????
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.
At Novo Nordisk, we believe in change. We are parents, colleagues, neighbors, and friends — people living with the complexities of serious diseases. And we believe in the combination of science and soul to help nurture each other back to good health. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients who need them.
For almost 100 years, we have been driving change to defeat diabetes, which has given us the experience and capability to help defeat other serious chronic diseases, including obesity, hemophilia and growth hormone disorders. We work for a future where lives are not limited—and we do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure the diseases we treat.