In this role, the selected candidate will prepare regulatory submissions (BLA and IND) and related maintenance documentation (amendments, supplements, annual reports, Drug and Site Master File maintenance, etc.) for US and other Regulatory Health Authorities within defined time schedule.
In this role, the selected candidate will evaluate complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals.
In this role, the selected candidate will advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.