Associate Director, Global Regulatory Affairs, Labeling

Genmab • Princeton, TX

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 Role The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and maintenance of global labeling documents (e.g., Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, Policy and Intelligence. 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 a scientific discipline is required; PharmD/PhD preferred.
• 3-5 years of pharmaceutical industry experience preferred, including 2-3 years Labeling (preferred) or related experience
• In-depth knowledge of current US and global regulations and guidance, especially as they relate to global labeling
• Understanding of clinical development of novel biologics products, preferably in oncology
• Experience developing and managing labeling content for at least one major submission (e.g., NDA/BLA), through negotiations and approval preferred
• Familiar with end-to-end labeling processes
• Ability to critically distinguish between “noise” and meaningful news to key stakeholders and senior leaders
• Ability to think strategically, communicate risks, and recommend course of action
• Self-starter with superior time management skills, ability to balance multiple tasks to meet priorities and timelines
• Ability to work independently or in teams.
• Ability to lead broad range of stakeholders at all levels internal and external to the company
• Strong attention to detail
• Effective communication skills, specifically excellent oral and written presentation skills.
• Strong sensitivity for a multicultural/multinational environment
• Proficiency with MS-Office Suite and Adobe Acrobat application and ability to work in electronic document management system

Responsibilities

• Lead the Labeling Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SmPC), and their associated Patient Labeling Documents.
• Serve as the labeling subject matter expert responsible for advising teams on global labeling strategies based on Genmab’s development programs, target product profile, and competitive labeling precedent.
• Act as Global Labeling Lead, supporting development, approval and maintenance of regional labeling (e.g., JPI)
• Manage new projects and projects of increased complexity including those involving 3rd party collaborators
• Keep up to date with global labeling guidelines and regulations as they relate to the development/maintenance of labeling documents and advise the LWG accordingly
• Advise LWG on the content of labels in the same therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labeling.
• Ensure proper development, review, approval, implementation, maintenance, distribution and tracking of labeling documents according to internal SOPs and external regulatory requirements.
• Prepare submission-ready labeling documents; Maintain and track labeling documents in the electronic system as appropriate.
• Participate in the development and maintenance of SOPs, work instructions, templates, and associated documents
• Monitor the regulatory environment, including surveillance of changes in major health authority guidances and regulations, trends, and regulatory developments.
• Manage process for dissemination of regulatory intelligence and subsequent impact assessment within Genmab
• Work closely with the global regulatory leads (GRLs), regional regulatory leads (RRLs) and global labeling leads (GLL) to support ad-hoc queries, providing novel insights to inform the regulatory strategies for development or marketed products.
• Support policy deliverables, e.g., call for comments efforts

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