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 Associate Director, Regulatory Policy will be responsible for US regulatory policy initiatives and activities at Novo Nordisk. This key role will be responsible for assessing, integrating, shaping, maintaining and advocating the company’s regulatory policy positions. The incumbent will work collaboratively to build and maintain relationships with key FDA staff, assess the current regulatory environment, and anticipate regulatory trends through a deep understanding of guidances, regulations and laws that impact Novo Nordisk’s business with FDA. He/she will develop and advocate the use of innovative regulatory strategies in line with the needs of the business with an understanding of the requirement to balance opportunity and risk.
Relationships
Reports to the Senior Director or Executive Director of Regulatory Affairs. Interacts with key company personnel both within and outside of Novo Nordisk-US. Collaborates with other departments to promote an understanding of the US regulatory environment, particularly FDA, and to influence cross-functional engagement for regulatory affairs. May act as FDA liaison on critical company issues. The Associate Director, US Regulatory Policy is responsible for collaboratively developing Novo Nordisk’s regulatory policy for the US, in conjunction with US Regulatory Affairs US Legal Affairs and other internal department staff and representing Novo Nordisk’s position to industry thought leaders and US regulators, particularly FDA. Building partnerships to deepen Novo Nordisk’s regulatory relationships and visibility in developing industry and FDA regulatory policy.
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.
The salary range for this position is between $148,290 to $259,510.
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.
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