Location: Princeton, NJ
Company: Novo Nordisk
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 backssing, 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, backss 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 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 Nordisk’s policies and responses to FDA draft regulations and guidance’s, as well as legislative initiatives impacting the FDA Manage interactions and communications with FDA on regulatory policy matters. 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.
(NNI) Monitor emerging regulatory policy issues in assigned areas, including issues arising from FDA or other regulatory authorities, Congress, within the medical 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 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 Nordisk’s 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 Senior management briefing memos, as needed.
Click Enter to preview the description of Essential Functions Continued Preview 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 8 years regulatory experience; 6 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.
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, interaction, gender identity, interactionual 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 -xyz X. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Management & Executive Jobs refer to positions within an organization that involve overseeing operations and making strategic decisions to guide the company towards its objectives. These roles are characterized by leadership responsibilities, high-level planning, and typically require extensive experience. Executives set the vision and goals, while managers ensure that daily activities align with these directives. Such positions often demand strong communication and interpersonal skills, as well as the ability to solve complex problems and adapt to changing business environments.
Management & Executive Jobs refer to positions within an organization where individuals are tasked with making strategic decisions, overseeing operations, and leading teams towards achieving business goals. These roles typically include titles such as manager, director, vice president, and CEO, and are characterized by their high level of responsibility, authority, and often, a requirement for extensive experience and leadership skills. Executives set the vision for the company, while managers implement strategies and policies to drive success. These jobs often involve complex problem-solving, strong communication abilities, and the capacity to influence and motivate others.
Management & Executive Jobs refer to high-level positions within an organization that involve overseeing operations, making strategic decisions, and leading teams towards achieving business objectives. Individuals in these roles typically have significant experience and expertise in their respective fields. They are responsible for setting goals, developing policies, and ensuring the effective management of resources. Executive roles often include titles such as CEO, CFO, COO, and department heads, among others. Characteristically, these jobs demand strong leadership skills, excellent communication abilities, and a capacity to think critically and solve complex problems.
Management & Executive Jobs refer to positions within an organization where individuals are tasked with making strategic decisions, overseeing operations, and leading teams towards achieving business goals. These roles typically include titles such as manager, director, vice president, and CEO, and are characterized by their high level of responsibility, authority, and often, a requirement for extensive experience and leadership skills. Executives set the vision for the company, while managers implement strategies and policies to drive success. These jobs often involve complex problem-solving, strong communication abilities, and the capacity to influence and motivate others.
