Description:
A Business, Securities & Intellectual Property Law Firm global life sciences practice, one of the largest in the U.S., is seeking a regulatory counsel with at least 10+ years of industry experience in drug/biologics development to join our FDA regulatory group.The ideal candidate will have deep expertise in FDA regulation of drugs, biologics, cellular and gene therapy products. The counsel should also have experience counseling biopharma companies in all stages of development, including preparing for pre-IND and pre-NDA/BLA meetings; reviewing INDs, NDAs/BLAs, and other submissions to FDA; negotiating clinical trial endpoints with FDA; preparation for OTP INTERACT meetings; reviewing briefing packages; providing strategic guidance on pipeline development, FDA designations and exclusivity analysis, PTE calculations and Orange Book listings; pharmacovigilance and adverse event reporting obligations; and advising companies on clinical study close-out procedures. Work experience at FDA CBER/CDER is highly preferred.
Our FDA regulatory group works with broad range of companies, including medical devices, drugs, biologics, diagnostics, digital health, research tools, cosmetics, dietary supplements, wellness products, and other consumer products. Given the firm's nexus to companies with next-generation products and innovative biotechnologies, we commonly help clients with novel technologies and therapeutics and develop FDA regulatory strategies for seeking marketing authorizations. 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 overlap with patent strategy, e.g., Orange Book listing for NDA applicants.
Candidates must have stellar academic credentials, excelling verbal, written and interpersonal skills. Successful candidates may sit in Seattle, Washington DC, Boston, San Francisco, Palo Alto, or San Diego with other locations considered for exceptional candidates.
