Posted:
5/1/2024, 5:00:00 PM
Location(s):
Capital Region of Denmark, Denmark ⋅ Copenhagen, Capital Region of Denmark, Denmark
Experience Level(s):
Senior
Field(s):
Legal & Compliance
Workplace Type:
Remote
At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
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, the candidate will represent RA in the 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 candidate may also be allocated as EU/ROW Regulatory Strategy Lead to one or multiple compounds in early or late development and 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. The position is based in Copenhagen and will report to the EU/ROW Regulatory Strategy Team Lead.
Responsibilities
The responsibilities of the role will include, but is not limited to:
Requirements
Moreover, you meet the following personal requirements:
Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly motivated team members across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.
About You
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed 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 guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website https://www.genmab.com/privacy.
Website: https://genmab.co.jp/
Headquarter Location: Nagano, Nagano, Japan
Employee Count: 1-10
Year Founded: 2017
IPO Status: Private
Last Funding Type: Seed
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