Vice President, Regulatory Affairs

About the Department

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is a diverse and collaborative group that engages with healthcare providers, develops and implements regulatory strategies, provides medical education, and collects data to support efficacy and new product development. The team focuses on patient-centered solutions and works to improve the quality of life for patients worldwide.

The Position

As Head of Regulatory Affairs and 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. It is responsible for NNI product submissions and approvals for the U.S. market, setting and executing regulatory strategy to maximize regulatory success across the product lifecycle, and representing NNI Regulatory Affairs externally. The role leads strategic engagement with the U.S. Food and Drug Administration (FDA), determines approval timing, manages post‑marketing commitments, and oversees crisis response.

Relationships

This position reports to the U.S. Organization (USO) Head of Clinical Development, Medical and Regulatory Affairs and is a member of the CMR Leadership Team. It manages internal relationships within NNI and Novartis A/S headquarters, collaborating with global regulatory affairs, medical, clinical, CDSE, patient safety, market access, and marketing teams. The role also maintains relationships with Key Opinion Leaders, regulatory bodies, and policy organizations.

Essential Functions

• Regulatory Strategy
  • Set and execute regulatory strategy to maximize regulatory success for the U.S. market.
  • Lead the team in raising awareness of regulatory trends that impact opportunities and access.
  • Build innovative strategies to support product lifecycle success.
  • Advise on licensing opportunities and implement strategy across the development portfolio.
  • Collaborate with cross‑functional teams to provide key regulatory considerations early in product planning.
• HA Interactions
  • Build and maintain relationships with the U.S. FDA across multiple therapeutic areas.
  • Represent NNI regulatory positions externally and lead engagement with stakeholders.
  • Ensure inspection readiness through training and education.
• Submissions and Approvals
  • Maintain oversight and accountability for regulatory strategy and submissions across the product lifecycle.
  • Leverage innovative data to drive lifecycle extension activities.
  • Interpret complex scientific issues and provide guidance to internal teams.
• Regional Excellence and Compliance
  • Maintain compliance with U.S. regulatory requirements and internal policies.
  • Manage significant compliance matters proactively.
  • Provide feedback to global teams and maintain relationships with the U.S. affiliate leadership.
• Promotional/Non‑Promotional Review
  • Review promotional content and non‑promotional materials to ensure consistency with guidelines.
• Managerial
  • Create the long‑term regulatory affairs strategy and operating model.
  • Lead cross‑functional collaboration and ensure team alignment in early product planning.
  • Attract and develop industry‑leading talent within the Regulatory Affairs team.

Development of People

Responsible for coaching and mentoring colleagues within Regulatory Affairs and the broader CMR organization.

Qualifications

• A Doctorate or advanced degree preferred; Life Science degrees preferred.
• 15+ years of pharmaceutical experience with progressive Regulatory Affairs responsibility; 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 with strategic planning for a large team; proven ability to engage, develop, and inspire talent.
• Proactive relationship building with regulatory bodies and key stakeholders.
• Extensive expertise in U.S. FDA regulatory and drug development processes with proven policy‑shaping experience.
• Ability to solve complex problems and make decisive decisions in ambiguous situations.
• Strong interpersonal, relationship management, and communication skills with the ability to influence without authority.
• Innovative mindset, digital literacy, and experience using real‑world evidence and patient‑reported outcomes in regulatory strategy.

Compensation

The base compensation range for this position is $336,900 to $589,600. This range is determined based on a number of factors. The position also includes a company bonus based on individual and company performance, long‑term incentive compensation, and company vehicles depending on level.

Benefits

Employees are eligible for medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; an employee assistance program; tuition reimbursement; voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance, and auto/home insurance. Time off is provided pursuant to sick time, flexible vacation, and parental leave policies.

Equal Opportunity

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.