Manager of Regulatory Affairs
Philadelphia, PA
Manger of Regulatory Affairs opportunity in Philadelphia with a global, biopharmaceutical company that also has a presence in Europe and California as well. They are continuing to establish themselves as leaders within the CNS, Oncology, and Hematology therapeutic areas and build upon their already successful product line. It is a very exciting time to join the company, since they are placing a heavy focus in IND and NDA submissions in order to further grow their catalogue of products.
The ideal candidate in this position will draw upon their experience with IND and NDA submissions, while also utilizing their expertise to provide regulatory strategy guidance and work cooperatively with multiple departments throughout the company. There is also an emphasis on being able to have frequent, effective interactions with the FDA and other regulatory affairs agencies as needed.
QUALIFICATIONS:
* 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.
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Manager of Regulatory Affairs
- Location Philadelphia
- Job type Permanent
- Salary Negotiable
- Discipline Regulatory
- Reference PR/255141_1582671785