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 complex generics.
The company is a research, global pharmaceutical company specialized in the development generics, APIs, and branded products. Since bringing their operations to the U.S., they have received more than 75 FDA Approvals and are continuing to grow at an incredibly fast pace. They are currently on track to file 20 or more ANDA's per year and are looking to develop 5 new branded products in 2020 to further build upon their already incredibly diverse catalogue.
The ideal candidate for this Director of Regulatory affairs role will have a background and skill set that is rich in complex generics experience, technical expertise, and previous work with large pharmaceutical companies. The majority of the product development work will focus on ANDA and 505(b)(2) filing, providing guidance on how to improve upon the process for quicker results.
* Develop effective regulatory strategies in support of the company's 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.
* Effectively communicate with various branches of the company on global scale.
* 10+ years experience of Regulatory Affairs in pharmaceutical development
* Experience with complex generics
* MS or PHD in relevant field.
* Knowledge of FDA's current requirements related to strategies and submissions.
* Knowledge of ANDA and 505(b)(2) submissions.