over 1 year ago
Currently seeking an 'Associate Director' to join the Regulatory Affairs team and support programs through Stage 1 and Stage 2. You will serve as the primary liaison with the FDA, working within the mAbs and small molecule departments.
- Primary FDA liaison
- Project management
- Represent global regulatory team
- Preparation of SOP’s
- Master's, PhD or PharmD in scientific background
- Expertise in Oncology, Immunology, or other Rare Disease
- Previous experience working on a global scale (phase 1-2 preferred)
- IND and DMF submission experience
- Background in CMC
Please direct all questions to Ryan Shaffer at firstname.lastname@example.org or call 347-305-6781.