Strategic Regulatory CMC Expert
3 weeks ago
The Regulatory Affairs CMC team at Genmab is seeking a highly skilled Associate Director to provide strategic regulatory CMC input to support worldwide development and commercialization.
- Develop and Execute Global Regulatory CMC Strategies: 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: Collaborate with cross-functional peers to facilitate and optimize product development.
- Prepare CMC Documentation: Plan, review and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.
- Respond to Health Authority Information Requests: In collaboration with CMC, plan and prepare responses to health authority information requests.
- Plan and Prepare Post-Approval Applications: Plan and prepare post-approval applications.
- Advise on Regulatory Legislation: Provide advice and guidance on EU, US and selected worldwide regulatory legislation for CMC topics.
- Evaluate and Communicate Regulatory Risks: Evaluate and communicate regulatory risks and challenges.
- Liaise with Health Authorities: Liaise and negotiate with global health authorities on regulatory CMC topics and represent Genmab at meetings and interactions with health authorities.
- Stay Informed on Regulatory Laws and Guidances: Remain informed on regulatory laws and guidances.
- Master of Science: Master of Science in pharmacy, engineering or equivalent.
- Industry Experience: Minimum of 5-10 years of industry experience within Regulatory Affairs CMC, with a strong understanding of compliance and biologics.
- Therapeutic Product Development: A track record in moving therapeutic products through various stages of development.
- Lifecycle Management: Experience with lifecycle management.
- English Proficiency: Proficient communication in English (verbal and written).
Genmab is a dynamic, global company collaborating with talented and experienced colleagues in Regulatory Affairs as well as within Genmab's CMC organization. Our Regulatory Affairs CMC team is robust and supportive, fostering a culture of collaboration and mutual support. We strive to be a highly trusted partner to the CMC organization.
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. We are committed to enabling the best work of others on the team and to fostering a collaborative team environment by offering support and sharing knowledge with your colleagues.
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