Regulatory Affairs Director
2 weeks ago
The Regulatory Affairs CMC team at Genmab is seeking a Director/Associate Director to support worldwide development and commercialization of biological products. The ideal candidate will have a strong understanding of compliance and biologics, with a track record of moving therapeutic products through various stages of development.
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.
- 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 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 Genmab:
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. For more than 20 years, its passionate, innovative, and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences.
Our commitment to diversity, equity, and inclusion:
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.
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