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
Genmab is looking for a Senior Manager/Associate Director, EU/ROW Regulatory Lead to be a part of our Global Regulatory Affairs organization.
In this role, you will represent European RA in the Global RA team. You will be allocated as EU/ROW Regulatory Strategy Lead to one or multiple compounds in late stage development.
It is expected that you will provide regulatory expertise and guidance on EU/ROW procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team to ensure an optimal EU/ROW regulatory strategy for the compound.
As well as being assigned to Clinical Trial Teams and work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of the clinical trial submissions in EU/ROW.
The position is based in Copenhagen and will report to the EU/ROW Regulatory Strategy Team Lead.
Responsibilities
- Act as EU/ROW Regulatory Lead for the assigned project(s) and be responsible for the development and execution of the EU/ROW regulatory strategy.
- Represent EU/ROW in the Global Regulatory Team(s).
- Lead the preparation of strategic regulatory documents, e.g. Briefing Packages, ODDs, PIPs, etc.
- Plan, prepare and lead EMA or national Scientific Advice procedures, as relevant.
- Evaluate regulatory risks and recommend mitigation strategies to the cross-functional teams and management.
- Monitor and assess 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 ways of working.
- Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities
Requirements
- Bachelor’s degree or equivalent in scientific discipline or health-related field. Master’s degree preferred.
- Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications.
- Experience in proactively planning and executing highly complex clinical submission strategies.
- Prior experience leading health authority meetings with the EMA or other health authorities.
- A good understanding of drug development and EU regulatory procedures.
- Experience within oncology and/or I&I will be a plus.
- Experience with PIPs will be a plus.
- Experience with development and regulatory requirements in ROW markets will be a plus.
- Strong project management skills.
Moreover, you meet the following personal requirements:
- Strong organizational, communication, and time management skills needed to lead 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 dedicated 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.
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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