Director of Regulatory Affairs
Central New Jersey
Our client is looking to hire for a Director of Regulatory Affairs with expertise in complex products and generics.
This company is a leading pharmaceutical organization specializing in producing generics and API's, with a catalogue of products being sold in the U.S. and globally. The ideal candidate will be one who can both provide leadership to team members underneath them and can simultaneously take on the regulatory submission responsibilities of this company's product development and provide guidance to employees underneath them.
RESPONSIBILITIES:
* Develop effective regulatory strategies in support of the company's specialty products and in accordance with US and EU legislation.
* Organization and coordination of new ANDAs/DMFs as well as the preparation of supplemental applications and amendments.
* Maintain an understanding of FDA regulations and procedures.
* Act as liaison and point of contact with FDA and other regulatory affairs organizations as needed.
REQUIREMENTS:
* 10+ years' experience of Regulatory Affairs in pharmaceutical development
* MS or PHD in relevant field.
* Knowledge of FDA's current requirements related to strategies and submissions.
* Knowledge of 505(b)(2) submissions.
* Experience with complex generics products.
* Solid relations and ability to communicate effectively with the FDA.