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Senior Director, Regulatory Affairs Strategy
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$206,250 - $343,750
Full-time
- 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.
- Evaluate various regulatory mechanisms to optimize product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, compassionate use, pediatric plans, diversity action plans) and ensure that they are implemented, if applicable.
- Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred) Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA) A broad knowledge of development and life-cycle management is preferred.
- 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.
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