Director, Global Regulatory Strategy & U.S. Regulatory Affairs, ConsumerProvided leadership in science and innovation, collaboration and communication, and culture and organization across complex global organizational matrices to deliver global pipelines and advance BCH competitive position in allergy, cough cold, pain & cardiovascular health Led team of regulatory professionals in applying knowledge of regulations, drug development, external environments, competitive landscapes, drug portfolios and disease states to shape global pipelines and develop strategies to bring new products to market and maintain existing marketing authorizations Prepared effective strategies and documentation for submissions, negotiations, and meetings on investigational and marketed new drugs (IND/NDA) with global health authorities  Developed clear, concise, and persuasive communications  Monitored the external environment for emerging risks, assessed and mitigated impactLegal Counsel, Bayer U.S. PharmaceuticalsIn addition to Director of Global Regulatory Strategy and U.S. Regulatory Affairs, served as Brand Attorney for the Pharmaceuticals Established Brands Business Legal Representative on Legal-Medical-Regulatory (LMR) Promotional Review Team (PRT) Reviewed and approved healthcare professional and consumer directed communications, medical information, portfolio strategy decks, brand plans, launch materials, press releases, market research materials and digital online marketing Participated in biweekly U.S. Pharmaceuticals Legal & Compliance Staff meetings. Provided other legal counsel as needed  Reviewed and approved service, sponsorship, consulting, pharmacovigilance, and advisory board agreements, and other contracts as needed

 Led team of ten in developing and implementing strategies for IND, NDA, ANDA, and 510(k) submissions, data generation, FDA meetings, negotiations, and product maintenance  Advised cross functional leadership on drug, device, cosmetic, and consumer goods law and regulation in driving approvals, differentiated claims, competitive strategies, classification, legal status, route to market, branding, labeling, ad promo, manufacturing, quality, submission, compliance, and enforcement issues Advised on intelligence, advocacy, and policy issues; CHPA and PCPC liaison Obtained 510(k) clearance for an artificial saliva device to treat xerostomia Researched, analyzed, and implemented Drug Supply Chain Security Act (DSCSA) requirements Researched, analyzed, and trained staff in Prescription Drug Labeling and Promotion regulations Identified risk and implemented training and education for Quality System Regulations (QSR) compliance

 Advised business partners on Rx drug law, healthcare law compliance, anti-spam law (CANSPAM), risk evaluation and mitigation strategies (REMS) and PhRMA Code Reviewed advertising and promotional material for launch of Otezla (apremilast)

 Resolved Medicare and Medicaid civil and administrative fraud and abuse cases, violations of EMTALA, STARK Law, False Claims Act (FCA), and Anti-Kickback Statute (AKS) through civil monetary penalties (CMP), corporate integrity agreements (CIA), and exclusions Participated in CIA negotiations and prepared written responses to CIA Annual Reports Wrote exclusion briefs for OIG Department Appeals Board (DAB) cases Wrote and negotiated settlement agreements for Self-Disclosure Protocol (SDP) cases Analyzed, summarized, and wrote assessments of OIG authority to exclude in EMTALA cases Researched, analyzed, and summarized complex issues concerning drugs and medical devices for Congressional reports drafted by the Office of Evaluations and Inspections (OEI) including OEI Final Report, “FDA’s Clearance of Medical Devices Through the 510(k) Process”