Director - Regulatory Affairs - Regulatory Policy

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 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 companys 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 Nordisks 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, Regulatory Policy & Intelligence. 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 US regulatory policy impacting Novo Nordisk priorities. May act as FDA liaison on critical company issues.

The 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 with US regulators and key external stakeholders to deepen Novo Nordisk’s regulatory relationships and reputation as a thought leader and partner in prioritized areas of regulatory policy. Collaborate with Global Regulatory Policy & Intelligence to create global vision for the regulatory environment.

Essential Functions

• Advise senior management of FDA requirements and standards related to drug and device development, life-cycle management and regulatory compliance activities. Build and maintain a strong relationship with the FDA
• Coordinate with appropriate internal staff to develop Novo Nordisks policies and responses to FDA draft regulations and guidances, as well as legislative initiatives impacting the FDA
• Manage interactions and communications with FDA on regulatory policy matters
• Liaise with outside scientific and professional organizations to represent Novo Nordisk on product and regulatory policy matters under the supervision of the VP, US Regulatory Affairs at Novo Nordisk, Inc.
• Monitor emerging regulatory policy issues in assigned areas, including issues arising from FDA or other regulatory authorities, Congress, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact Novo Nordisks regulatory strategy or product portfolio. In consultation with Senior Director, Regulatory Policy & Intelligence, coordinates and leads internal teams to address regulatory policy issues
• Participate in appropriate regulatory project team meetings and rehearsals for FDA meetings to learn about product matters likely to surface which may require involvement/action of Regulatory Policy staff
• Participate in industry and professional meetings to maintain competency on regulatory policy issues and present at professional meetings to demonstrate Novo Nordisks scientific excellence
• Plan and manage interactions with NNI and NN A/S regulatory management and liaison staff for submission of product applications and other related interactions with FDA
• Proactively monitors emerging scientific trends/strategies, both internally and externally, to shape and influence changes in the US regulatory environment. Under the supervision of the Sr. Director, Regulatory Policy, the incumbent will represent Novo Nordisk in assigned areas on pharma industry committees and maintain productive relationships with industry staff and FDA staff to ensure productive Agency interactions
• Work with other internal Novo Nordisk departments, including legal, public affairs, competitive intelligence, product safety, promotional review, commercial, medical, clinical, and manufacturing to build cross-functional strategies to address Novo Nordisk business objectives and patient needs
• Represent Novo Nordisk before trade associations and other committees to foster relationships and build advocacy strategies that enhance Novo Nordisk’s objectives
• Prepare presentations and assist in the development of Sr. management briefing memos, as needed

Physical Requirements

0-10% overnight travel required.

Qualifications

• A Doctorate or advanced degree preferred in science, health care, public health, health policy, or law
• A minimum of 10 years regulatory experience; 8 years FDA/HHS and/or regulatory policy experience. Proven ability to develop robust and successful regulatory policy positions and strategies
• Documented success in regulatory aspects of US regulatory policy development and ability to influence the FDA environment
• Excellent communication and leadership skills. Ability to establish sound working relationships, within NNI, at NN A/S and with FDA staff as appropriate
• Excellent collaboration skills and ability to work in a team environment and individually
• Experience and knowledge of the current FDA requirements and industry standards, particularly in the drug, device, and combination product regulatory area

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.