Global Regulatory Affairs Lead
2 days ago
The Regulatory Affairs team at Genmab A/S is seeking an experienced professional to fill the role of Director/Associate Director, Global Regulatory Affairs. The successful candidate will be responsible for providing strategic regulatory guidance on CMC topics, collaborating with cross-functional peers, and planning and preparing CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.
In this dynamic role, you will leverage your expertise in global regulatory affairs to develop and execute sound and robust global regulatory CMC strategies for biological products during early and late-stage development and lifecycle. You will work closely with the Senior Director of Regulatory Affairs CMC and the Regulatory Affairs CMC team to ensure alignment with company objectives.
Key Responsibilities
- Develop and execute global regulatory CMC strategies for biological products.
- 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.
- Liaise and negotiate with global health authorities on regulatory CMC topics and represent Genmab at meetings and interactions with health authorities.
- Evaluate and communicate regulatory risks and challenges.
Requirements
- Master 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).
About Us
Genmab is an international biotechnology company committed to transforming the lives of patients through innovative antibody therapeutics. Our team is passionate about developing and delivering novel antibody therapies to patients. We foster a collaborative environment that values diversity, equity, and inclusion. We are dedicated to protecting our employees' personal data and privacy.
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