Regulatory Affairs Director
6 days ago
Our Culture
Genmab fosters a culture of collaboration, mutual respect, and open communication. Our team is composed of talented individuals who share a passion for innovation and excellence. We strive to create an environment where every employee feels valued, supported, and empowered to contribute to our shared success.
About the Position
We're seeking a highly skilled and experienced professional to join our Regulatory Affairs CMC team as a Director/Associate Director. The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and the ability to collaborate effectively with cross-functional teams.
Responsibilities
- Develop and execute regulatory CMC strategies for biological products.
- Collaborate with cross-functional teams to optimize product development.
- Prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.
- Liaise and negotiate with global health authorities on regulatory CMC topics.
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