Regulatory Affairs Analyst

Freyr Global Regulatory Newwark, NJ Full-time

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Regulatory Affairs Analyst - (Masters or equivalent with one year experience or other suitable qualifications) - Required experience in publishing regulatory documents in eCTD format; archiving & indexing regulatory files; FDA technical specifications; eCTD submission; PDUFA, GDUFA, regulatory SOP's; and work/w Liquent Insight Publisher, and ISI Toolbox. Relocation and travel to unanticipated locations possible.

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Freyr Global Regulatory

Newwark, NJ