Denmark Job Openings
Genmab
Director/Associate Director, Global Regulatory Affairs - CMC
Copenhagen
FULL TIME
September 4, 2024
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Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle
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Collaborate with cross functional peers to facilitate and optimize product development
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Plan, review and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages
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In collaboration with CMC, plan and prepare responses to health authority information requests
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Plan and prepare post-approval applications
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Provide advice and guidance on EU, US and selected worldwide regulatory legislation for CMC topics
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Evaluate and communicate regulatory risks and challenges
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Liaise and negotiate with global health authorities on regulatory CMC topics and represent Genmab at meetings and interactions with health authorities
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Remain informed on regulatory laws and guidances
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Master of Science in pharmacy, engineering or equivalent
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Minimum of 8+ years of industry experience within Regulatory Affairs CMC, with a strong understanding of compliance and biologics
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A track record in moving therapeutic products through various stages of development
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Experience with preparation of BLAs and preferably experience with lifecycle management
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Proficient communication in English (verbal and written)
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You have excellent collaboration and communication skills
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You thrive being challenged and working in cross functional teams
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You are able to work independently with an ability to drive projects to successful outcomes
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You have a quality mindset and are able to prioritize your work in a fast paced and changing environment
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You are result-oriented and committed to contributing to the overall success of Genmab
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You enjoy fostering a collaborative team environment by offering support and sharing knowledge with your colleagues
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so
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