Careers

Job Description

The Regulatory Affairs Specialist will provide regulatory affairs operations support to RRD International, LLC senior regulatory staff and product development teams in the tracking, preparation, and review of regulatory submissions for new investigational drugs, biologics, and medical devices, including writing/editing, literature searches, quality control checks, formatting, publishing/compilation, and submission of documents to Regulatory Health Authorities. Will log and track regulatory documents, publications, and other relevant materials for programs. Participates in project teams and coordinates assigned specific regulatory operation publishing/compilation of documents for submission to Regulatory Health Authorities.

Requires a bachelor's degree or equivalent, preferably in science or healthcare discipline, 4 years or more of relevant regulatory health experience, and working knowledge of regulations relevant to the area of expertise including US FDA requirements and ICH CTD guidance for drugs and biologics.

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From backgrounds in pharma/biotech, CRO management and at the FDA, the RRD team delivers a unique combination of knowledge, experience and strategic thinking to product development, across all major classes and therapeutic areas.

If you would like to be a part of our world-class team, please complete the form below and attach your resume.

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