Job Description

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 healthcare 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

As Head of Regulatory Affairs, and as a member of the Novo Nordisk, Inc. (NNI) Clinical Development, Medical and Regulatory Affairs (CMR) Leadership Team, this position defines and leads the strategic agenda for the Regulatory Affairs team in an increasingly dynamic healthcare environment, be responsible for NNI product submissions and approvals for US market, set and execute regulatory strategy to maximize regulatory success for product lifecycle , and represents NNI Regulatory Affairs position from an external perspective. This position leads all strategic engagement with the U.S. Food and Drug Administration (FDA), determining approval timing, labour breadth, post-marketing commitments and crisis response in the company’s largest market.

Relationships

This position reports to the United States Organization (USO) Head of Clinical Development, Medical and Regulatory Affairs and is a member of the CMR LT. It is accountable for managing multiple internal relationships within NNI and NN A/S (HQ) as well as other affiliates, with key stakeholders being global regulatory affairs, Medical, Clinical, CDSE, and Patient Safety, Market Access and marketing teams. It is a critical position representing NNI to the external community from an external perspective by leading with influence during interactions with Key Opinion Leaders, regulatory bodies and other key stakeholders (FDA, policy-based organizations, advise on patient advocacy engagement). The incumbent will have a dotted line reporting relationship to the Senior VP, Regulatory, Quality & Clinical Reporting in HQ.

Essential Functions

• Regulatory Strategy:
  • Set and execute regulatory strategy to maximize regulatory success for product lifecycle for USO
  • Leads the team to raise awareness and critical thinking around trends that impact both regulatory opportunities and access; maintains view of how to strengthen product development plan(s) and adopt regulatory strategies accordingly
  • Experience in building innovative and robust strategies to maximize regulatory success for product lifecycle
  • Advises on diligence for licensing opportunities as appropriate
  • Expertise in implementing strategy across the development portfolio, marketed products and/or line extensions within the assigned franchise and/or therapeutic areas
  • Works as a core member of the CMR LT cross-functionally; leads by influence and collaborates with peers in Medical, Clinical, CDSE, and Market Access on end-to-end product planning by providing key Regulatory considerations and “art of the possible” planning early in the product lifecycle
• HA Interactions:
  • Build and maintains strong relationships with US FDA across multiple domains / therapeutic areas to position NNI as policy shaper and industry leader in regulatory engagement and innovation
  • Represents NNI Regulatory Affairs positions from an external perspective by leading with influence during interactions with Key Opinion Leaders and regulatory/health agency/HTA bodies
  • Ensure that the organization is inspection-ready, supported by training and education related to inspection readiness
• Submissions and Approvals:
  • Maintains oversight and accountability for regulatory strategy and submissions for the portfolio, across each product’s lifecycle. Leverage new and innovative data types to drive lifecycle extension activities, and develop teams to cultivate “art of the possible” thinking regarding these data types as related to submissions and regulatory planning
  • Interprets complex scientific issues and provides guidance to team members across the organization
• Regional Excellence and Compliance:
  • Maintains compliance and adheres to regulatory internal policies and processes in line with US regulatory requirements
  • Proactively manages significant compliance matters in conjunction with internal experts
  • Maintains strong working relationships with Global organization, reflecting best of Global guidance in USO affiliate leadership for Regulatory Affairs while also providing feedback to Global about USO affiliate positioning and requirements
• Promotional/Non-promotional Review:
  • Experience in reviewing promotional content and non-promotional materials (PSUR, DSUR, RMP, IB, SmPC, HCP letters etc.) for maintaining consistency with documented guidelines
• Managerial:
  • Creates the vision and design for the long-term Regulatory Affairs strategy and operating model
  • Leads cross-functional team collaboration with relevant functional leaders to stand up and execute cross-functional ways of working; ensure alignment and participation of relevant Regulatory Affairs team members in up-front product planning to best position products for differentiated approval
  • Attracts industry-leading talent to build and grow leaders internally within the Regulatory Affairs team; build a culture of collaboration throughout the organization; focus on building and growing teams with diverse experiences across the CMR organization

Development of People

Responsible for coaching and mentoring colleagues in RA and across CMR as relevant.

Qualifications

• A Doctorate or advanced degree preferred; Life Science degrees preferred
• 15+ years of pharmaceutical experience, including progressive Regulatory Affairs responsibility, and 5+ years of leadership experience in a large pharmaceutical company required. Experience in diabetes and/or metabolic disease areas preferred. Legal or Quality experience a plus
• Supervisory experience demonstrating extensive strategic planning and enterprise mindset for a business of a large sized team, and proven ability to engage, manage, develop and inspire a large team
• Ability to proactively build relationships with regulatory bodies and other key stakeholders (FDA, policy-based organizations, advise on patient advocacy engagement)
• Extensive expertise in U.S. FDA regulatory and drug development processes, with a proven ability to shape regulatory policy and build trusted relationships with FDA leadership
• Ability to execute and solve highly complex problems and make bold decisions even when facing ambiguity or in the absence of complete information
• Strong interpersonal, relationship management and excellent communication skills (both verbal and written) with clear ability to impact and influence without authority and utilize cross-functional collaboration skills
• Innovative mindset, digital literacy, and experience using RWE and PROs in regulatory strategy and policy

The base compensation range for this position is $336,900 to $589,600. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.