Associate Director, Global Regulatory Affairs, Labeling
The Antibody Society, Princeton, NJ, United States
Genmab is dedicated to building extraordinary futures by developing antibody products that change lives and the future of cancer treatment.
The Role The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily lead 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 position may be based in Princeton, New Jersey (requires onsite presence 60% of the time) or be U.S. remote.
Responsibilities
Lead the Labeling Working Group (LWG) to develop and maintain labeling documents, including Company Core Data Sheets, Core Safety Information, United States Package Inserts, Summary of Product Characteristics, and associated Patient Labeling Documents.
Serve as the labeling subject matter expert, 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 complex projects, including those involving third‑party collaborators.
Keep up to date with global labeling guidelines and regulations and advise the LWG accordingly.
Advise LWG on 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 and maintain tracking of labeling documents in the electronic system as appropriate.
Participate in the development and maintenance of SOPs, work instructions, templates, and associated documents.
Additional Regulatory Policy and Intelligence Support
Monitor the regulatory environment, including surveillance of changes in major health authority guidances and regulations, trends, and regulatory developments.
Manage the process for dissemination of regulatory intelligence and subsequent impact assessment within Genmab.
Work closely with global regulatory leads, regional regulatory leads, and global labeling leads to support ad‑hoc queries, providing novel insights to inform regulatory strategies for development or marketed products.
Support policy deliverables, e.g., call for comments efforts.
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 in labeling (preferred) or related experience.
In‑depth knowledge of current U.S. 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 courses of action.
Self‑starter with superior time‑management skills, able to balance multiple tasks to meet priorities and timelines.
Ability to work independently or in teams and lead a 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 and multinational environment.
Proficiency with MS‑Office Suite and Adobe Acrobat, and ability to work in an electronic document management system.
Salary For U.S. based candidates, the proposed salary band is $174,320.00–$261,480.00.
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.
About You
Genuinely passionate about our purpose.
Brings precision and excellence to all that you do.
Believes in our rooted‑in‑science approach to problem‑solving.
Is a generous collaborator who can work in teams with a broad spectrum of backgrounds.
Take pride in enabling the best work of others on the team.
Can grapple with the unknown and be innovative.
Has experience working in a fast‑growing, dynamic company (or has a strong desire to).
Works hard and is not afraid to have a little fun while doing so.
Location Genmab supports an agile working environment. The position may be based in Princeton, New Jersey, or may be U.S. remote.
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The Role The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily lead 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 position may be based in Princeton, New Jersey (requires onsite presence 60% of the time) or be U.S. remote.
Responsibilities
Lead the Labeling Working Group (LWG) to develop and maintain labeling documents, including Company Core Data Sheets, Core Safety Information, United States Package Inserts, Summary of Product Characteristics, and associated Patient Labeling Documents.
Serve as the labeling subject matter expert, 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 complex projects, including those involving third‑party collaborators.
Keep up to date with global labeling guidelines and regulations and advise the LWG accordingly.
Advise LWG on 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 and maintain tracking of labeling documents in the electronic system as appropriate.
Participate in the development and maintenance of SOPs, work instructions, templates, and associated documents.
Additional Regulatory Policy and Intelligence Support
Monitor the regulatory environment, including surveillance of changes in major health authority guidances and regulations, trends, and regulatory developments.
Manage the process for dissemination of regulatory intelligence and subsequent impact assessment within Genmab.
Work closely with global regulatory leads, regional regulatory leads, and global labeling leads to support ad‑hoc queries, providing novel insights to inform regulatory strategies for development or marketed products.
Support policy deliverables, e.g., call for comments efforts.
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 in labeling (preferred) or related experience.
In‑depth knowledge of current U.S. 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 courses of action.
Self‑starter with superior time‑management skills, able to balance multiple tasks to meet priorities and timelines.
Ability to work independently or in teams and lead a 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 and multinational environment.
Proficiency with MS‑Office Suite and Adobe Acrobat, and ability to work in an electronic document management system.
Salary For U.S. based candidates, the proposed salary band is $174,320.00–$261,480.00.
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.
About You
Genuinely passionate about our purpose.
Brings precision and excellence to all that you do.
Believes in our rooted‑in‑science approach to problem‑solving.
Is a generous collaborator who can work in teams with a broad spectrum of backgrounds.
Take pride in enabling the best work of others on the team.
Can grapple with the unknown and be innovative.
Has experience working in a fast‑growing, dynamic company (or has a strong desire to).
Works hard and is not afraid to have a little fun while doing so.
Location Genmab supports an agile working environment. The position may be based in Princeton, New Jersey, or may be U.S. remote.
#J-18808-Ljbffr