Associate Director, Global Regulatory Affairs, Advertising & Promotion

Genmab • Plainsboro Township, NJ

1d • Hybrid

About The Position

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!
The Associate Director, Global Regulatory Affairs, Advertising & Promotion Compliance is responsible for ensuring that all promotional materials and activities comply with the applicable laws, regulations, and guidelines in the US and other markets. This role will be responsible for the review of promotional materials, providing strategic guidance to the commercial teams.
Work 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.

Requirements

• Bachelor's degree in life sciences, pharmacy, or related field. Advanced degree preferred.
• Minimum of 6-8 years of experience in Regulatory Advertising and Promotion Compliance.
• Expert knowledge of US laws, regulations, and guidances related to pharmaceutical advertising and promotion.
• Strong leadership, communication, and interpersonal skills.
• Ability to work collaboratively and influence cross-functional teams.
• Ability to manage multiple projects and prioritize competing deadlines.
• Ability to think strategically and creatively to solve complex regulatory challenges.

Nice To Haves

• Experience with accelerated approval products is strongly preferred

Responsibilities

• Provide regulatory guidance and direction to the cross-functional Medical, Regulatory and Legal (MeRL) Committee.
• Ensure timely and accurate submission of promotional materials to the FDA OPDP.
• Monitor and assess the impact of new or changing regulations, guidances, and enforcement actions on promotional activities.
• Provide training and education to internal and external stakeholders on regulatory requirements and best practices for advertising and promotion.
• Establish and maintain effective relationships with regulatory agencies, alliance partners, and industry associations.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 501-1,000 employees