Director, Regulatory Affairs (Oncology)

A mid-size, oncology pharmaceutical company is seeking a Director of Regulatory Affairs for their growing regulatory team. The Regulatory Affairs Director will work through full product lifecycle, including exposure to IND's, NDA's and advertising and promotional materials.

* Manage all of the regulatory affairs promotional material review activities.
* Oversee regulatory strategy for successful approvals
* Understand policies, key personnel, and regulatory climate at the FDA and maintain a good working relationship with the FDA.
* Address regulatory agency requirements to pursue approval of additional clinical indications and new dosage forms.
* Assist in representing organization at FDA. Respond to FDA contacts to assure efficient review and approval of submissions.
* Manage the preparation and submission of INDs and NDAs
* Manage the planning and implementation of meetings with regulatory agencies.
* Act as primary regulatory agency contact
* Manage clinical development program

Experience, Education, Skills:

* 7+ Years regulatory experience
* B.S. in related discipline
* RAC a plus
* Experience with reviewing of promotional materials
* Experience with strategy and submission of NDA, BLA and IND's

To find out more about Real Staffing please visit www.realstaffing.com