Remote Regulatory Advertising & Promotion Lead

Genmab; Princeton (NJ); Hybrid; USD 104,000 - 157,000; Full time

Benefits offered by this job

401(k) Plan: 100% match on the first 6

Health Benefits: Medical, dental, and

Vision insurance

Voluntary plans: critical illness and

Paid vacation and holidays

Parental leave

Commuter benefits

Tuition reimbursement

Lifestyle Spending Account

Job summary

Genmab is seeking a Manager, Regulatory Advertising & Promotion to lead OPDP submissions and coordinate FDA promotional materials. This role offers hybrid work options in the U.S., with 20-40% remote work and collaboration across Regulatory, Medical, and Commercial teams.

You will manage Form FDA 2253 submissions, ensure compliance, and support inquiries, while advancing promotional review processes. Requires 5+ years in pharma/biotech regulatory roles; bachelor's in life sciences; advanced

Qualifications

• Bachelor’s degree in life sciences or regulatory affairs; advanced degree preferred.
• 5+ years in pharma/biotech regulatory roles; 9+ years if no bachelor’s degree.
• Experience with FDA-regulated promotional materials and OPDP submissions.

Responsibilities

• Prepare, coordinate, and execute OPDP submissions to FDA, including Form FDA 2253.
• Ensure timely submission of promotional materials and maintain records.
• Coordinate electronic submissions and troubleshoot regulatory issues.
• Support responses to FDA inquiries and cross-functional collaboration.

Skills

Attention to detail

Cross-functional collaboration

Written and verbal communication

Regulatory affairs

Regulatory submissions

Education

Bachelor's degree in life sciences or regulatory affairs

Advanced degree preferred

Tools

Form FDA 2253

eCTD submissions

Veeva PromoMats

Document management systems

Job description

Genmab is seeking a Manager, Regulatory Advertising & Promotion to lead OPDP submissions and coordinate FDA promotional materials. This role offers hybrid work options in the U.S., with 20-40% remote work and collaboration across Regulatory, Medical, and Commercial teams.

You will manage Form FDA 2253 submissions, ensure compliance, and support inquiries, while advancing promotional review processes. Requires 5+ years in pharma/biotech regulatory roles; bachelor's in life sciences; advanced