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Celldex is a clinical stage biotechnology company dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate. To help us achieve this we have built an environment where innovative and talented people thrive. We are seeking an Associate Director, Regulatory Affairs to join a well-established team in New Haven, CT. The Associate Director, Regulatory Affairs will be responsible for execution of Celldex regulatory strategy and delivery of submissions and documentation of the highest quality, accuracy, and compliance across the company’s portfolio. This role will also be the point of contact for the US FDA, Celldex study teams and CROs.
Execution of Celldex regulatory strategy and delivery of submissions and documentation of the highest quality, accuracy, and compliance across the company’s portfolio
Collaborate cross-functionally within Celldex to support the coordination and planning of submission deliverables
Ensure the timely maintenance of clear, accurate and accessible records of submissions and health authority interactions
Be a point of contact for the US FDA, Celldex study teams and CROs
Communicate and escalate topics appropriately and participate in process optimization within the Regulatory Affairs department and across Celldex
Complete training on technical aspects of electronic submissions in order to provide back-up within the department.
Bachelor’s degree with 5-10 years of relevant drug development experience
Degree in science or health-related discipline; Advanced degree preferred
Knowledge and understanding of FDA and ICH regulations and guidelines is required
Ability to collaborate in a cross-functional team environment with successful ability to manage project teams
Keen attention to detail and the ability to handle multiple tasks and manage a dynamic work environment
Ability to work efficiently, independently and to identify work-related tasks proactively
Strong organizational, computer and documentation skills and an ability to prioritize effectively
Excellent interpersonal skills. Both verbal and written communication are essential in this collaborative work environment, and to interact effectively with regulatory authorities
Experience with IND, NDA, BLA or other marketing application submissions preferred
Celldex Therapeutics (NASDAQ: CLDX) was founded based on a fundamental scientific belief that harnessing the power of the immune system would break significant barriers in drug development for a host of devastating diseases. We are dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly effect critical pathways to improve the lives of patients with inflammatory diseases and many forms of cancer.
Many of our clinical programs seek to leverage the power of the immune system’s response by combining therapeutic approaches to maximize their potential. Key to this strategy is our ability to understand our own asset base while also identifying promising external technologies that will complement it. In 2005, Celldex was spun out of the New Jersey based biopharmaceutical company Medarex (acquired by the Bristol-Myers Squibb Company) and, in connection with this transaction, Celldex retains the rights to obtain exclusive commercial licenses to proprietary monoclonal antibodies raise...d against certain antigens utilizing the Medarex UltiMAb technology platform. Since its inception, Celldex has also acquired five companies, folding in five assets, and in-licensed/purchased an additional two assets.