Associate Director - Regulatory Affairs - Advertising & Promotion

5-7 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

Job Title: Associate Director, Regulatory Affairs - Advertising & Promotion

Location: Plainsboro, United States

Department: Clinical, Medical and Regulatory (CMR)

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 teams within the organization. CMR interacts with healthcare providers, develops and implements regulatory strategies with the FDA, provides medical education, and supports efficacy and product development. The department is driven by a patient-centered focus, committed to helping patients globally. The team is continuously seeking innovative ways to improve patients' lives.

Position Overview:

The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory guidance on advertising and promotional activities for assigned products. The role involves ensuring compliance with FDA regulations, guidance, and company policies, while supporting business goals.

Key Responsibilities:

Strategic Guidance:

Advise on advertising and promotion strategies based on the current regulatory environment and competitive landscape.
Assess regulatory risks and advise on mitigation strategies to ensure compliance with US regulatory requirements.
Stay updated on laws, regulations, and policies governing advertising and promotion of pharmaceuticals and devices.

Promotion Development:

Provide regulatory input on product messages and promotional materials across functional teams.
Advise on regulatory strategies and solutions for challenging promotional concepts to meet business objectives.
Ensure timely and accurate updates of promotional materials in accordance with changes in the US Prescribing Information.

Regulatory Collaboration:

Collaborate with Regulatory Affairs teams to provide input on study designs, labels, and feasibility of promoting data/claims.
Assist in US labeling negotiations, ensuring changes in prescribing information are reflected in promotional materials.
Support pre-launch and launch activities, including developing launch materials and new claims in collaboration with Commercial, Medical, and Legal teams.

Promotional Review:

Advise on and ensure efficient and compliant Promotional Review Board (PRB) processes.
Serve as the primary regulatory reviewer for advertising and promotion of assigned products.
Liaise with the FDA’s Office of Prescription Drug Promotion (OPDP) regarding advertising and promotional materials.
Oversee the submission of materials to OPDP for advisory comment and ensure timely submission with FDA Form 2253.

Physical Requirements:

0-10% overnight travel required. Flexible.

Qualifications:

Education:
- Bachelor’s degree required; advanced degree in life sciences preferred.
Experience:
- A minimum of 7 years of experience in the pharmaceutical/biologics industry or related field required.
- At least 5 years of promotional review experience preferred.
- Advanced knowledge of pertinent FDA regulations.
- Experience with Subpart H preferred.
Skills:
- Detail-oriented, well-organized, and deadline-driven.
- Excellent verbal and written communication skills.
- Experience leading projects in regulatory areas preferred.
- Strong interpersonal skills; ability to work with staff at all levels.
- Ability to work independently with minimal supervision.

Equal Opportunity Employer:

Novo Nordisk is an equal opportunity employer, offering equal 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.

Special Assistance:

If you require special assistance or accommodations to apply, please contact us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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