$100K - $150K*
As Regulatory Science team member, you will work with the FDA and the EMA, as well as national regulatory authorities globally, thinking out of the box and finding innovative ways to collaborate. We see regulators as partners. Our core principles are to be transparent and proactive in our communication with them and to use science-based reasoning.
We seek an experienced Associate Director who will be responsible for overseeing programs in our Oncology franchise to developing registration strategies for our innovative cellular therapy programs from pre- IND to Phase 3 and registration. You will be responsible for the preparation, submission and approval of INDs, CTAs, pediatric investigation plans, orphan drug designations, and managing corresponding interactions with regulatory authorities. In addition, you will be responsible for upcoming marketing applications, leading teams through submission, approval and post approval. You must have the ability and drive to manage, build
Valid through: 2020-5-19
$80K - $100K
10 days ago