Manager, Regulatory Advertising & PromotionWork arrangement: 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: EducationBachelor's degree in life sciences, pharmacy, regulatory affairs, or a related discipline required. Advanced degree (PharmD, PhD, MS, JD, or equivalent) may be preferred depending on level.
Experience- Pharmaceutical or biotechnology industry experience, preferably within Regulatory Affairs, Advertising & Promotion, Regulatory Operations, Medical/Legal/Regulatory review, or a related function.
- 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
