FDA DRUG/BIOLOGICS REGULATION COUNSEL (1167)
Description
Our client, a global life sciences firm with one of the largest practices in the U.S., is seeking a regulatory counsel with a minimum of 10 years of industry experience in drug/biologics development to join their FDA regulatory group. The ideal candidate will have deep expertise in FDA regulation of drugs, biologics, cellular and gene therapy products, and experience counseling biopharma companies in all stages of development. This includes preparing for pre-IND and pre-NDA/BLA meetings, reviewing INDs, NDAs/BLAs, and other submissions to FDA, negotiating clinical trial endpoints with FDA, and advising companies on clinical study close-out procedures. Experience at FDA CBER/CDER is highly preferred. The counsel will also support corporate teams in M&As, asset deals, IPOs, and other complex transactions, and support patent teams in areas where FDA regulation overlaps with patent strategy. Candidates must have excellent academic credentials and strong verbal, written, and interpersonal skills. The position can be based in Seattle, Washington DC, Boston, San Francisco, Palo Alto, or San Diego, with other locations considered. Interested candidates are encouraged to apply below or confidentially reach out at inquiry@khawajapartners.com.
Job #1167
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