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USA Job Offer - Regulatory Affairs Specialist



We are an established pharmaceutical company whose focus is bringing in high quality products at a cost that people can afford.


If you are a Regulatory Affairs professional interested in taking part in the process of making drugs that can help people in their day to day lives, please read on!


Top Reasons to Work with Us


- Join an industry leader in the development, manufacturing and marketing pharmaceuticals products

- Our employees are our greatest asset and we know it!

- The stability of a large organization with the upward mobility of a start-up


What You Will Be Doing


- Review source documents for ANDA/IND/NDA submissions

- Ensure compliance with current submission requirements

- Obtain non-clinical and clinical research and associated documents

- Author and review regulatory submission documents

- Review original applications of ANDA/IND/NDA and their subsequent amendments or supplements

- Work interdepartmentally to issues raised by the regulators.


What You Need for this Position


- Hands-on experience in R&D, Quality control or commercial manufacturing is highly desirable.

- Track record in analytical, formulation or manufacturing process development

- Background in pharmaceutical regulations


We are actively interviewing so APPLY TODAY!


Applicants must be authorized to work in the U.S.


Additional ways to apply


Preferred Skills

CyberCoders


Comments


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