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Regulatory Affairs CMC Director/Associate Director Role
2 months ago
We are seeking a highly skilled and experienced Director/Associate Director, Global Regulatory Affairs to join our Regulatory Affairs CMC team. This is an exciting opportunity to work in a dynamic and innovative environment, collaborating with talented colleagues in Regulatory Affairs and within Genmab's CMC organization.
Key Responsibilities- Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle.
- Collaborate with cross-functional peers to facilitate and optimize product development.
- Plan, review, and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.
- In collaboration with CMC, plan and prepare responses to health authority information requests.
- Plan and prepare post-approval applications.
- Provide advice and guidance on EU, US and selected worldwide regulatory legislation for CMC topics.
- Evaluate and communicate regulatory risks and challenges.
- Liaise and negotiate with global health authorities on regulatory CMC topics and represent Genmab at meetings and interactions with health authorities.
- Masters of Science in pharmacy, engineering or equivalent.
- Minimum of 8+ years of industry experience within Regulatory Affairs CMC, with a strong understanding of compliance and biologics.
- A track record in moving therapeutic products through various stages of development.
- Experience with preparation of BLAs and preferably experience with lifecycle management.
- Proficient communication in English (verbal and written).
We offer a competitive salary of around $140,000 per year, depending on experience, as well as a range of benefits including:
- A comprehensive health insurance package.
- A generous pension scheme.
- A flexible working policy, with opportunities for remote work.
- Professional development and training opportunities.
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. With a passionate, innovative, and collaborative team, we have invented next-generation antibody technology platforms and leveraged translational research and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.
