Associate Director :- Regulatory Affairs - Advertising & Promotion

5+ years

Not Disclosed

Plainsboro United States

10 Feb. 13, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position

Associate Director, Regulatory Affairs – Advertising & Promotion

Location

Plainsboro, United States

Job Category

Regulatory Affairs & Safety Pharmacovigilance

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. Our responsibilities include:

Healthcare provider interactions
Developing and implementing regulatory strategies with the FDA
Providing medical education
Collecting data to support efficacy and new product development

With a patient-centered approach, we continuously innovate to improve lives. Join us in changing lives for a living—are you ready to make a difference?

The Position

The Associate Director, Regulatory Affairs – Advertising & Promotion provides strategic regulatory guidance on advertising and promotion for assigned products. This includes ensuring compliance with FDA regulations, company policies, and business objectives.

Key Responsibilities

Regulatory Strategy & Compliance

Provide strategic guidance on advertising and promotion based on the current regulatory environment and competitive landscape.
Assess risk and advise on mitigation strategies to balance compliance with business needs.
Stay updated on laws, regulations, and policies governing pharmaceutical advertising and promotion.
Maintain compliance with FDA requirements, including timely submission of promotional materials to OPDP with FDA Form 2253.

Cross-Functional Collaboration

Work closely with Regulatory Affairs, Legal, Commercial, and other stakeholders to achieve company goals.
Establish and maintain strong working relationships with OPDP reviewers.
Play a critical role in pre-launch and launch activities, including messaging and claim development.

Promotional Review & Labeling

Serve as a primary regulatory reviewer for advertising and promotion materials.
Provide regulatory input on study designs and US labels to assess promotional feasibility.
Ensure promotional materials reflect updates in US Prescribing Information in a timely manner.
Support the development and implementation of an efficient and compliant Promotional Review Board (PRB) process.

Training & Development

Provide FDA advertising and promotion training to Novo Nordisk employees and agents.
Act as a subject matter expert on regulatory strategy for advertising and promotion.

Relationships & Reporting

Reports to Senior Director, Regulatory Affairs – Advertising & Promotion.
Works cross-functionally with Regulatory, Legal, Commercial, and Medical teams.

Physical Requirements

0-10% overnight travel required.
Flexible work environment.

Qualifications

Education & Experience

Bachelor’s degree required (Life Sciences preferred); advanced degree preferred.
Minimum of 7 years of experience in the pharmaceutical/biologics industry or a related field.
5+ years of experience in promotional review preferred.

Technical Skills & Knowledge

Advanced knowledge of FDA regulations related to pharmaceutical advertising and promotion.
Strong project management skills with experience leading regulatory projects.
Experience with subpart H preferred.

Soft Skills

Detail-oriented and well-organized.
Strong verbal and written communication skills.
Strong interpersonal skills with the ability to interact at all levels.
Ability to work independently with minimal supervision.

Equal Opportunity Employer

Novo Nordisk is committed to diversity and inclusion. We ensure equal employment opportunities for all applicants regardless of:

Race, ethnicity, color
Religion, sex, gender identity, sexual orientation
National origin, disability, or protected veteran status

If you need assistance or accommodation during the application process, please contact 1-855-411-5290 (for accommodation requests only).

Join Team Novo Nordisk and help us make what matters.

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