Requisition ID 44995BR<br/>Title Director, Regulatory Policy<br/>Job Category Regulatory Affairs<br/>Job Description Purpose:<br/>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 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.<br/><br/>Relationships:<br/>• Reports to the Executive Director, 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.<br/>• 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.<br/>• Building partnerships to deepen Novo Nordisk’s regulatory relationships and visibility in developing industry and FDA regulatory policy.<br/><br/>Essential Functions:<br/>• 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.<br/>• Coordinate with appropriate internal staff to develop Novo Nordisk’s policies and responses to FDA draft regulations and guidances, as well as legislative initiatives impacting the FDA.<br/>• Manage interactions and communications with FDA on regulatory policy matters.<br/>• Maintain liaison 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.<br/>• 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 Nordisk’s regulatory strategy or product portfolio. In consultation with Executive Director, Regulatory Affairs, coordinates and leads internal teams to address regulatory policy issues.<br/>• 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.<br/>• Participate in industry and professional meetings to maintain competency on regulatory policy issues and present at professional meetings to demonstrate Novo Nordisk’s scientific excellence.<br/>• 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.<br/>• 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.<br/>• 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.<br/>• Represent Novo Nordisk before trade associations and other committees to foster relationships and build advocacy strategies that enhance Novo Nordisk’s objectives.<br/>• Prepare presentations and assist in the development of Sr. management briefing memos, as needed.<br/><br/>Physical Requirements:<br/>• 0-10% o vernight travel required<br/><br/>Qualifications:<br/>• A Doctorate or advanced degree preferred in science, health care, public health, health policy, or law.<br/>• 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.<br/>• Documented success in regulatory aspects of US regulatory policy development and ability to influence the FDA environment.<br/>• Excellent communication and leadership skills. Ability to establish sound working relationships, within NNI, at NN A/S and with FDA staff as appropriate.<br/>• Excellent collaboration skills and ability to work in a team environment and individually.<br/>• Experience and knowledge of the current FDA requirements and industry standards, particularly in the drug, device, and combination product regulatory area.<br/>Department CMR - REG AFFAIRS (2)<br/>Position Location US - Washington, DC<br/>City Washington<br/>State/Provinces US - DC
<br/><br/>At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
<br/><br/>With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
<br/><br/><p class="eeo_desc">Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.<br/><br/>
Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.<br/><br/>
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