Associate Director, Global Regulatory Affairs, Strategy

n we would love to have you join us!

Genmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of our Global Regulatory Affairs organization.

In this role, you will work in close collaboration with the Global Regulatory Lead on a compound in late-stage development to implement the US regulatory strategy for multiple new indications and/or serve as a Global Regulatory Lead for assigned projects. You will act as a contact person with FDA and provide regulatory expertise and guidance on global procedural and documentation requirements to the Global Regulatory Team and cross-functional teams to ensure an optimal regulatory strategy for the compounds. You must have strong project management capabilities and will be responsible for planning, coordinating, and executing timely and high-quality submissions to regulatory authorities.

This is a hybrid position based in our Princeton, NJ office, and can work remotely 40% of the time. You will report to the Global Regulatory Strategy Team Lead.

Responsibilities

The responsibilities of the role will include, but is not limited to:

• Act as the US/Global Regulatory Leader (GRL) for assigned project(s) and be responsible for the development, implementation and maintenance of US/global regulatory strategies (in line with Target Product Profile).

• As the US Regulatory lead, serve as the FDA contact person for assigned project(s) and be responsible for the implementation and maintenance of the US regulatory submission strategy

• Lead the strategic development of briefing materials and prepare teams for global health authority meetings.

• Evaluate regulatory risk and recommend mitigation strategies to global regulatory lead to ensure optimal regulatory success.

• Represent US RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required for the assigned project(s).

• Represent GRA in global Compound Development Teams (CDT) to successfully meet project deliverables while adhering to regulatory requirements for programs and products. Participate in regulatory sub-team, clinical management team, and labeling working group meetings, as required for the assigned projects

• Participate in the development of and assess the appropriateness of submission documentation to support successful IND and (s)BLA submissions.

• Evaluate various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and ensure that they are implemented, if applicable.

• In collaboration with Global Regulatory Lead, plan, prepare and lead FDA meetings as relevant.

• Support global regulatory lead and labeling strategy lead in development of the Company Core Data Sheep and US Prescribing Information.

• Responsible for maintenance of the IND.

• Monitor and assess global and US regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products.

• Maintain an updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and working instructions

Requirements

• A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field.
• Minimum of 5 years of experience in Regulatory Affairs.
• A solid understanding and experience in oncology drug development is required.
• Strong project management skills.
• Prior experience interacting with FDA as sponsor contact person.
• Experience with managing first wave BLA and/or sBLA submissions is highly preferred.
• Experience in supporting multiple complex submissions, maintenance of regulatory documentation, and other regulatory support activities.
• Moreover, you meet the following personal requirements:

  • Strong organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously

  • Must have attention to detail and be able to solve problems with minimal supervision

  • Be able to work independently with an ability to drive projects to successful outcomes

  • Robust cross-functional teamwork skills and enjoy working in a global environment

  • Skills in building and maintaining internal and external collaborative relationships to achieve shared goals

  • Highly motivated and self-driven individual who enjoys being challenged

  • Able to prioritize your work in a fast paced and changing environment

  • Goal-oriented and committed to contributing to the overall success of Genmab

Additional Job Description

• Develop and execute sound and robust Global Regulatory strategies for drug products at various stages of development

• Provide direction and guidance to project development team and drive regulatory activities to ensure likelihood of regulatory approvals

• Proactively evaluate and communicate regulatory risks and challenges and relevant mitigatory actions, to senior leadership and project team

• Prepare/oversee/review/maintain regulatory documentation (e.g. regulatory sections of clinical applications, marketing applications, Health Authority briefings; agency responses) as applicable, in markets within scope

• Drive compliance by providing guidance and advice to cross-functional teams on market legislation and other regulatory requirements as applicable

• Liaise and collaborate with internal teams (e.g. QA, manufacturing), external teams (e.g. contract manufacturing, CRO, affiliates), and regulatory & health authorities, in relation to matters of regulatory importance within scope

For US based candidates, the proposed salary band for this position is as follows:

$165,600.00 - $248,400.00

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

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can grapple with the unknown and be innovative

• You have experience working in a fast-growing, dynamic company (or a strong desire to)

• You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.