Associate Director, Global Regulatory Labeling, Policy and Intelligence
Genmab, Princeton, NJ, United States
Global Regulatory Labeling, Policy and Intelligence Associate Director
We are looking for a leader who will take responsibility for the development and maintenance of global labeling documents (e.g., Core Data Sheet, USPI, EU SmPC, and related patient information) for Genmab’s portfolio of products. The role may be based in our Princeton, New Jersey site (requiring 60% onsite presence per our hybrid policy) or be US‑remote. The position reports to the Sr. Director, Labeling, Policy and Intelligence within Global Regulatory Affairs.
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 advising teams on global labeling strategies based on Genmab’s development programs, target product profile, and competitive precedent.
Act as Global Labeling Lead, supporting development, approval and maintenance of regional labeling (e.g., JPI).
Manage complex new projects, including those involving third‑party collaborators.
Keep up to date with global labeling guidelines and regulations, advising the LWG accordingly.
Advise LWG on label content relative to therapeutic class competitors and labeling trends to support optimized labeling.
Ensure proper development, review, approval, implementation, maintenance, distribution and tracking of labeling documents in accordance with internal SOPs and external regulatory requirements.
Prepare and maintain submission‑ready labeling documents and track them in the electronic system.
Participate in developing and maintaining SOPs, work instructions, templates and related documents.
Additional regulatory policy and/or intelligence support may include:
Monitoring the regulatory environment and surveillance of changes in major health‑authority guidelines.
Managing the process for dissemination of regulatory intelligence and impact assessment within Genmab.
Collaborating with global and regional regulatory leads to support ad‑hoc queries and provide insights for regulatory strategies.
Supporting policy deliverables such as 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 or related areas.
In‑depth knowledge of current US and global labeling regulations and guidance.
Understanding of clinical development of novel biologics, preferably in oncology.
Experience developing and managing labeling content for at least one major submission (e.g., NDA/BLA) through negotiations and approval.
Familiarity with end‑to‑end labeling processes.
Ability to discern meaningful regulatory news for stakeholders and senior leaders.
Strategic thinking, risk communication, and recommendation of actions.
Strong time‑management and multitasking skills.
Ability to work independently or in teams and to lead stakeholders at all levels.
Attention to detail.
Excellent oral and written presentation skills.
Sensitivity for a multicultural/multinational environment.
Proficiency with MS‑Office Suite, Adobe Acrobat and electronic document management systems.
Salary (US) $174,320.00 – $261,480.00. Actual offers will consider qualifications, experience and location. Additional compensation may include discretionary bonuses and long‑term incentives.
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 discretionary paid parental leave.
Support Resources – Child and adult backup care, family support programs, financial wellness tools and emotional support.
Additional Perks – Commuter benefits, tuition reimbursement and a Lifestyle Spending Account for wellness and personal expenses.
About You
You are passionate about our purpose.
You bring precision and excellence to all you do.
You value a rooted‑in‑science approach to problem‑solving.
You collaborate well with a broad range of backgrounds.
You help enable the best work of others on the team.
You are innovative and can grapple with the unknown.
You have experience working in a fast‑growing dynamic company or a strong desire to.
You work hard and are not afraid to have fun while doing so.
#J-18808-Ljbffr
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 advising teams on global labeling strategies based on Genmab’s development programs, target product profile, and competitive precedent.
Act as Global Labeling Lead, supporting development, approval and maintenance of regional labeling (e.g., JPI).
Manage complex new projects, including those involving third‑party collaborators.
Keep up to date with global labeling guidelines and regulations, advising the LWG accordingly.
Advise LWG on label content relative to therapeutic class competitors and labeling trends to support optimized labeling.
Ensure proper development, review, approval, implementation, maintenance, distribution and tracking of labeling documents in accordance with internal SOPs and external regulatory requirements.
Prepare and maintain submission‑ready labeling documents and track them in the electronic system.
Participate in developing and maintaining SOPs, work instructions, templates and related documents.
Additional regulatory policy and/or intelligence support may include:
Monitoring the regulatory environment and surveillance of changes in major health‑authority guidelines.
Managing the process for dissemination of regulatory intelligence and impact assessment within Genmab.
Collaborating with global and regional regulatory leads to support ad‑hoc queries and provide insights for regulatory strategies.
Supporting policy deliverables such as 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 or related areas.
In‑depth knowledge of current US and global labeling regulations and guidance.
Understanding of clinical development of novel biologics, preferably in oncology.
Experience developing and managing labeling content for at least one major submission (e.g., NDA/BLA) through negotiations and approval.
Familiarity with end‑to‑end labeling processes.
Ability to discern meaningful regulatory news for stakeholders and senior leaders.
Strategic thinking, risk communication, and recommendation of actions.
Strong time‑management and multitasking skills.
Ability to work independently or in teams and to lead stakeholders at all levels.
Attention to detail.
Excellent oral and written presentation skills.
Sensitivity for a multicultural/multinational environment.
Proficiency with MS‑Office Suite, Adobe Acrobat and electronic document management systems.
Salary (US) $174,320.00 – $261,480.00. Actual offers will consider qualifications, experience and location. Additional compensation may include discretionary bonuses and long‑term incentives.
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 discretionary paid parental leave.
Support Resources – Child and adult backup care, family support programs, financial wellness tools and emotional support.
Additional Perks – Commuter benefits, tuition reimbursement and a Lifestyle Spending Account for wellness and personal expenses.
About You
You are passionate about our purpose.
You bring precision and excellence to all you do.
You value a rooted‑in‑science approach to problem‑solving.
You collaborate well with a broad range of backgrounds.
You help enable the best work of others on the team.
You are innovative and can grapple with the unknown.
You have experience working in a fast‑growing dynamic company or a strong desire to.
You work hard and are not afraid to have fun while doing so.
#J-18808-Ljbffr