Regulatory Affairs Associate Director
1 month ago
Genmab is seeking an experienced Associate Director to join its Regulatory Affairs CMC team. The successful candidate will be responsible for developing and implementing global regulatory strategies for biological products during early and late stage development, and lifecycle management.
The ideal candidate will have a strong understanding of compliance and biologics, with a minimum of 10 years of industry experience in Regulatory Affairs CMC. They will be responsible for planning, reviewing, and preparing CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.
The Associate Director will also be responsible for providing advice and guidance on EU, US, and selected worldwide regulatory legislation for CMC topics, evaluating and communicating regulatory risks and challenges, and liaising and negotiating with global health authorities on regulatory CMC topics.
Responsibilities- Develop and implement global regulatory strategies for biological products during early and late stage development, and lifecycle management
- 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
- Master of Science in pharmacy, engineering, or equivalent
- Minimum of 10 years of industry experience in Regulatory Affairs CMC
- Strong understanding of compliance and biologics
- Excellent collaboration and communication skills
- Ability to work independently and drive projects to successful outcomes
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, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.
Genmab is committed to fostering workplace diversity at all levels of the company and believes it is essential for its 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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