What are the responsibilities and job description for the Associate Director, Regulatory Affairs position at Novo Nordisk, Inc.?
Associate Director, Regulatory Affairs w/ Novo Nordisk Inc. in Plainsboro, NJ. Act as a liaison w/ Novo Nordisk Inc (NNI) & Novo Nordisk A/S (NNAS) depts for the prep of docmntation necssry for submissn of apps reltd to prscriptn drug & device prods. Apprv spcfied regltry submssns. Must possess a Master’s degree in Regltry Affairs or a rltd field & 3 yrs of [or a Bach degree & 5 yrs of prgrsvly respnsbl] exp in regltry affairs in the pharm industry. Exp must incl: US regs, incl prprg, filing & prfrmg lifecycle mgmt of invstigatnl & mktg apps & all suppriv amndmts, supplmts & annual rprts to the (US-FDA) in eCTD format; Hlth authority meetg prep incl U.S. Type A, B, C, & Advisory committee; Clinical Trial Apps (CTAs/INDs) submssn to US regltry agencies & mgmt of regltry aspects of clinical trials in accrdnce w/ Good Clinical Practices (GCP) reqmts & 21 CFR regs. Approx 10% domestic & int'l trvl. Telecomm permitted. Email res to Novo Nordisk Inc. at NNIGlobal@novonordisk.com, Ref# ADRA9314
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