Director - Regulatory Affairs Advertising & Promotions

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

The Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice on advertising and promotion for assigned products in accordance with business goals and objectives, FDA regulations and guidance’s, and company policies.

 

Relationships

Develop and maintain positive rapport and working relationships with Regulatory Affairs, Legal, Commercial, and other cross-functional stakeholders to accomplish company goals. Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director, Regulatory Affairs - Advertising & Promotion.

 

Essential Functions

• Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape
• Assess risk and advise on mitigation strategies to meet overall business need, while maintaining compliance with US regulatory requirements and company operating procedures
• Maintain up-to-date knowledge of laws, regulations, and policies enforced by Federal and State governments as they relate to advertising and promotion of pharmaceuticals and devices
• Apply regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to promotional issues, while ensuring regulatory compliance and effectively managing business risks
• Creatively advise on the development of product messages and materials across multiple functional areas, and propose regulatory strategy and solutions to challenging promotional concepts that meet business objectives
• Provide training in FDA regulations for advertising and promotion to employees and agents of Novo Nordisk
• Collaborate with Regulatory Affairs colleagues to provide input to study designs or US labels regarding feasibility of promoting potential data/claims
• Participate/assist in US labeling negotiations as necessary. Ensure that changes in US Prescribing Information are reflected in current promotion and advertising in a timely manner
• Play a critical role in pre-launch and launch activities as necessary, including the development of launch materials/new claims by collaborating with Commercial, Medical and Legal
• Advise in the development and implementation of strategies to maintain efficient and compliant Promotional Review Board (PRB) process
• Serve as a primary regulatory advertising and promotion reviewer for assigned products
• Liaison with OPDP regarding advertising and promotion for assigned products. Oversees preparation and submission of draft introductory materials to OPDP for advisory comment
• Ensure company compliance with FDA requirements, including timely and accurate submission of advertising and promotional materials to OPDP with FDA Form 2253
• Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape
• Assess risk and advise on mitigation strategies to meet overall business need, while maintaining compliance with US regulatory requirements and company operating procedures
• Maintain up-to-date knowledge of laws, regulations, and policies enforced by Federal and State governments as they relate to advertising and promotion of pharmaceuticals and devices
• Apply regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to promotional issues, while ensuring regulatory compliance and effectively managing business risks
• Creatively advise on the development of product messages and materials across multiple functional areas, and propose regulatory strategy and solutions to challenging promotional concepts that meet business objectives

 

Qualifications

• Bachelor’s degree in a health- or science-related field and/or an advanced degree
• A minimum of 11 years of pharmaceutical/biologics industry experience required, with 6 years of promotional review experience preferred
• Experience with promotion of a product with conditional approval (Subpart H) highly preferred
• Ability to establish sound working relationships with individuals possessing different levels of skill and background is necessary
• Excellent communication and leadership skills are essential
• Ability to effectively communicate business issues across all levels of the organization, negotiate business decisions, evaluate risk, and work toward solutions
• Experience and knowledge of current FDA requirements; experience handling interactions with FDA

 

The base compensation range for this position is $187,000 to $300,000. 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.