Manager, Regulatory Advertising & Promotion

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

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

Manager, Regulatory Advertising & Promotion

This role offers flexibility to work away from the office for 20%-40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.

Job Description

OPDP Submission Responsibilities

• Prepare, coordinate, and execute submissions of prescription drug promotional materials to FDA OPDP, including materials submitted using Form FDA 2253.
• Ensure required promotional materials are submitted at the appropriate time of initial dissemination or publication, as applicable.
• Compile submission-ready packages and verify required components for
• Form FDA 2253
• Pre-submission packages for accelerated approval products
• Coordinate electronic submission activities and ensure packages meet applicable FDA technical requirements.
• Maintain accurate records of OPDP submissions, correspondence, submission dates, versions, and acknowledgments.
• Perform quality-control checks to ensure that submitted materials correspond to the final approved versions released for use.
• Partner with Regulatory Operations and other functions to troubleshoot submission issues and maintain compliant submission processes.
• Support responses to FDA inquiries regarding promotional materials and assist with regulatory correspondence when necessary.

Regulatory Ads & Promo Training and Compliance

• Monitor changes in FDA regulations, enforcement activities, guidance documents, advisory letters, and OPDP enforcement trends that may affect company promotional practices.
• Participate in development and maintenance of company policies, SOPs, work instructions, and training related to advertising and promotion.
• Support inspection readiness and internal or external audits involving promotional review and OPDP submission records.
• Develop training and other resources for Commercial, Medical, and other stakeholders regarding FDA advertising and promotion requirements.

Qualifications

Education

A minimum of a Bachelor's degree in life sciences, pharmacy, regulatory affairs, or a related discipline required (or equivalent years of experience); Advanced degree (PharmD, PhD, MS, JD, or equivalent) preferred.

Experience

• A minimum of 5+ years of Pharmaceutical or biotechnology industry experience, preferably within Regulatory Affairs, Advertising & Promotion, Regulatory Operations, Medical/Legal/Regulatory review, or a related function (9+ years of experience required in lieu of bachelor’s degree).
• Experience with FDA-regulated prescription drug promotional materials.
• Experience preparing or managing OPDP submissions strongly preferred.
• Familiarity with electronic regulatory submission processes and document-management or promotional-review systems.
• Understanding of FDA regulations and guidance applicable to prescription drug advertising and promotion.

Knowledge & Skills

• Knowledge of OPDP processes and Form FDA 2253 submissions.
• Strong attention to detail and document/version-control discipline.
• Ability to manage multiple materials and submission deadlines simultaneously.
• Strong written and verbal communication skills.
• Demonstrated ability to work effectively within highly cross-functional teams

Preferred Experience

• Experience supporting marketed prescription drug products in the U.S.
• Hands-on experience with promotional material review platforms and regulatory submission systems.
• Experience with Veeva PromoMats or similar systems.
• Familiarity with eCTD and electronic FDA submission processes.
• Experience supporting product launches, label updates, or high-volume promotional submission environments.
• Knowledge of FDA enforcement trends involving prescription drug promotion.

For US based candidates, the proposed salary band for this position is as follows:

$104,400.00---$156,600.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When You Join Genmab, You’re Joining a Culture That Supports Your Physical, Financial, Social, And Emotional Wellness. Within The First Year, Regular Full-time U.S. Employees Are Eligible For

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.