Regulatory Affairs Director
1 week ago
About Genmab
We are a global biotechnology company dedicated to creating innovative antibody therapies that transform lives. Our passionate team of experts is driven by a shared purpose: to improve patient outcomes through cutting-edge science and collaboration.
Job Overview
We seek an experienced Director/Associate Director, Regulatory Affairs CMC to join our team in Copenhagen, Denmark. This exciting role will play a key part in shaping our regulatory strategy for biological products and collaborating with cross-functional teams to drive product development.
Responsibilities
- Develop and execute global regulatory strategies for biologics during early and late stage development, and lifecycle.
- Collaborate with 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.
- 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.
Requirements
- Master's degree in pharmacy, engineering, or equivalent.
- Minimum 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).
What We Offer
- A competitive salary of approximately €120,000 per year.
- An exciting opportunity to work in a dynamic, global company collaborating with talented colleagues.
- A robust and supportive Regulatory Affairs CMC team fostering a culture of collaboration and mutual support.
- The position is based in Copenhagen, Denmark, and is hybrid.
About You
- 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 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.
Genmab's Commitment to Diversity, Equity, and Inclusion
We are committed to fostering a workplace culture that values diversity, equity, and inclusion. We believe it is essential for our continued success and strive to create a workplace where everyone feels welcome, valued, and empowered to contribute their best work.
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