Associate Director - Regulatory Affairs - AD Promo

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 health-care-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 Associate 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 guidances, 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 with manager oversight 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 Physical Requirements 0-10% overnight travel required.

• Flexible. Qualifications A Bachelor’s degree required; life science and advanced degree preferred A minimum of 7 years of experience in pharmaceutical / biologics industry or related field required, with 5 years of promotional review experience preferred Advanced knowledge of pertinent FDA regulations Broad hands-on related pharmaceutical experience and FDA regulatory experience Detail & deadline oriented;
• well-organized Excellent verbal & written communication skills Experience leading projects in specific regulatory area preferred Good interpersonal skills;

ability to interact with staff on all levels Works independently with minimal supervision We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

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, 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.