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.
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, with a strong catalogue already of oral/injectable anti-infectives and cardiovascular products.
The ideal candidate will work heavily on their branded products by drawing upon their experience in submissions, technical expertise, and background in large pharmaceutical companies. The majority of the work will focus on ANDA filing and following through with the submission process.
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.
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Director, Regulatory Affairs
- Location New Jersey
- Job type Permanent
- Salary Negotiable
- Discipline Regulatory
- Reference PR/250356_1580304964