Our client is looking to hire for a Director of Regulatory Affairs with expertise in complex products and complex generics. This position has opened up because the former Director of Regulatory Affairs has been promoted to a Senior Director level, reflecting a common trend this company has of encouraging advancement and growth.
The company is a research driven, global pharmaceutical company specialized in the development of 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 of complex generics experience, technical expertise, and work with large pharmaceutical companies. The majority of the product development work will focus on ANDA and 505(b)(2) filing, providing regulatory strategy guidance on how to improve upon these processes for quicker results.
RESPONSIBILITIES:
* 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.
REQUIREMENTS:
* 10+ years of in Regulatory Affairs and pharmaceutical development
* Experience with complex generics/background in the generics industry
* MS or PHD in relevant field.
* Knowledge of FDA's current requirements related
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Director of Regulatory Affairs
- Location New Jersey
- Job type Permanent
- Salary Negotiable
- Discipline Regulatory
- Reference PR/263892_1591135353