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Regulatory Associate - IV · Tarrytown, NY
This position in Regulatory Affairs:
-involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of Regeneron's preclinical and clinical drug development programs.
-provides guidance to multidiscplinary teams on the content, format, style of Regulatory submissions to Regulatory authorities.
-edits scientific sections of submission to comply with regulatory requirements.
-assists with the writing, review and preparation of IND applications amendments, annual reports and other regulatory documents and correspondence.
Strong organizational and negotiation skills, excellent written and verbal communication skills and an advanced proficiency in Microsoft Office and desktop publishing applications are necessary.
Experience and Skills:
A minimum of a bachelor's degree in a scientific discipline, biomedical, engineering, or related area is required. Previous experience in pharmaceutical development with biotechnology products is highly desirable. RAC certification by the Regulatory Affairs Professional Society is desirable. The successful candidate must have three to five years of experience conducting regulatory...
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