Senior Regulatory Affairs Manager
1 day ago
Genmab is a cutting-edge international biotechnology company that strives to improve the lives of patients through innovative antibody therapeutics. With over 20 years of experience, our passionate and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences to create a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.
We are committed to fostering a workplace diversity at all levels of the company and 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.
As Senior Regulatory Affairs Manager, you will have the opportunity to work in a fast-growing, dynamic company and contribute to the overall success of Genmab. You will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple, often highly complex, clinical trial submission activities. You will also 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.
The ideal candidate will have a minimum of Bachelor's degree or equivalent in scientific discipline or health-related field, with a minimum of 8 years of experience in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications. You should have experience in proactively planning and executing highly complex clinical submission strategies and prior experience leading health authority meetings with the EMA or other health authorities.
In this role, you will be part of our Global Regulatory Affairs organization and work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of the clinical trial submissions in EU/ROW. You 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.
The estimated salary for this position is DKK 1,200,000 per year, based on industry standards and location. As an employee of Genmab A/S, you will enjoy a competitive benefits package, including comprehensive health insurance, flexible working hours, and opportunities for professional growth and development.
If you are passionate about our purpose and genuinely care about our mission to transform the lives of people with cancer, we encourage you to apply for this exciting opportunity. Please submit your application, including your resume and cover letter, to us.
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