Chief Counsel Fda amp Regulatory

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Chief Counsel FDA & Regulatory
The candidate will provide legal guidance in preparation for audits and inspections by the FDA, and in responding to FDA 483s and enforcement actions, developing remediation work plans, and conducting market withdrawal/recall/field action analyses. Will provide legal advice and guidance regarding FDA Regulation including regulation relating to Product Clearances; development strategies, including with respect to clinical trial design and regulatory pathways; regulatory strategy and pre-market applications (including for digital health and other combination products); premarket notifications, including 510(k)s and PMAs; manufacturing; post-market (including any product modifications) and product end-of life. Provide counseling in connection with post-market reporting, including MDR reporting, field corrective actions, CAPA, complaint handling and similar matters. Advise on legal questions relating to sunshine reporting and clinical trial transparency initiatives (e.g., ct.gov and EudraCT requirements, researcher requests for clinical trial data, Policy 0070, provision of plain language summaries under EU Clinical Trial Regulation). Actively counsel business partners and other attorneys regarding physician self-referral law (Stark); health care services reimbursement and value-based purchasing; and related topics. Provide legal support to corporate compliance in its development and implementation of policies and procedures, as well as trainings of sales, marketing, legal, field finance and other personnel on regulatory matters and other relevant topics as well as on investigations and CAPA programs. Provide solutions-oriented and strategic legal advice relating to the company’s interactions with FDA, including crafting legal arguments for inclusion in regulatory submissions and helping teams prepare for formal meetings with FDA and advisory committees, and partnering closely with quality teams, maintain a state of inspection readiness. Advise on issues related to FDA’s expedited programs for serious conditions, such as accelerated approval, fast track designation, breakthrough designation, priority review, as well as on exclusivity issues. Specific expertise required in statutes, regulations and guidance concerning: GxP, drug development, regulatory submission standards, expedited programs for serious conditions, promotion and scientific exchange, Hatch-Waxman, compassionate use, Orphan Drug Act, and DQSA. Solid working knowledge of other laws, regulations, and industry standards that affect the development and commercialization of pharmaceutical and biotechnology products, including AKS, FCPA, OIG guidelines and opinions; clinical trial reporting laws, Sunshine Act/transparency laws; privacy laws, product liability, and industry standards (e.g., PhRMA guidelines, ICMJE and GPP standards, ACCME guidelines). In partnership with Firm’s Public Affairs team, provide legal advice to inform and shape advocacy before Congress, FDA, and other federal and state bodies and agencies with respect to existing and/or emerging regulatory policies. Provide legal advice in connection with regulatory due diligence for M&A activities. Provide legal advice to sales, marketing, finance, sourcing and procurement and other departments to develop and refine regulatory and legal contract terms. Assist in development and periodic refinement of various corporate policies, initiatives and/or programs relating to food and drug regulatory issues.

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