Remote-Eligible Regulatory Ad & Promo Manager

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

Benefits offered by this job

401(k) match on contributions

Health benefits

Paid time off and parental leave

Tuition reimbursement

Commuter benefits

Job summary

Genmab, a leading biotechnology company, is seeking a Manager for Regulatory Advertising & Promotion to lead OPDP submission activities. This role requires coordinating submissions to FDA, maintaining records, and ensuring promotional materials comply with FDA rules.

It offers flexible work arrangements and a strong compensation package. Ideal candidates bring 5+ years in regulatory affairs, experience with OPDP submissions, and familiarity with eCTD; advanced degrees are a plus.

Qualifications

• Bachelor's degree in life sciences, pharmacy, regulatory affairs, or related discipline required
• Advanced degree (PharmD, PhD, MS, JD, or equivalent) may be preferred depending on level
• 5+ years of pharmaceutical/biotech regulatory affairs experience
• Experience with FDA-regulated promotional materials and OPDP submissions
• Familiarity with eCTD and electronic FDA submission processes

Responsibilities

• Prepare, coordinate, and execute submissions of prescription drug promotional materials to FDA OPDP
• Ensure materials are submitted at the appropriate time of initial dissemination
• Coordinate submission packages and verify components (Form FDA 2253, pre-submission packages)
• Coordinate electronic submission activities and ensure regulatory packages meet FDA requirements
• Maintain records of submissions, correspondence, dates, versions and acknowledgments
• Perform quality-control checks against final approved materials
• Collaborate with Regulatory Operations and other functions to troubleshoot submissions
• Support responses to FDA inquiries and regulatory correspondence
• Monitor changes in FDA regulations and guidance related to advertising and promotion
• Develop training resources on advertising and promotion requirements
• Support inspections/readiness and audits related to promotional review

Skills

Attention to detail

Cross-functional teamwork

Written and verbal communication

Project/time management

Regulatory affairs knowledge

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

Veeva PromoMats

FDA submission systems

Job description

Genmab, a leading biotechnology company, is seeking a Manager for Regulatory Advertising & Promotion to lead OPDP submission activities. This role requires coordinating submissions to FDA, maintaining records, and ensuring promotional materials comply with FDA rules.

It offers flexible work arrangements and a strong compensation package. Ideal candidates bring 5+ years in regulatory affairs, experience with OPDP submissions, and familiarity with eCTD; advanced degrees are a plus.