Manager of Regulatory Affairs
Manger of Regulatory Affairs opportunity in Philadelphia with a global, biopharmaceutical company that also has a presence in Europe and California.
The role focuses on providing regulatory strategy guidance for new product development in Oncology, Hematology, and CNS. This company has established themselves as global leaders within the CNS/Sleep Medication space and are now focusing on new product development to further build upon their success in this therapeutic area, on top of expanding their Hematology and Oncology product line.
Employees at this organization often praise the company for having an incredible company culture that puts the needs of their employees and their families first, while still further establishing themselves as global pharmaceutical leaders.
* 5+ years of experience within Regulatory Affairs and the pharmaceutical industry.
* Prior experience with IND and NDA submission process.
* Experience providing Regulatory Affairs strategy guidance and comfortability working cooperatively with multiple departments throughout company.
* Ability to interact frequently and effectively with FDA and other regulatory affairs authorities as needed.
* Experience within CNS, Oncology, or Hematology therapeutic areas a plus.