• Supervised all communication with FDA for 2 investigational products in the following division: o Anti-Infective Products• Provided strategic regulatory guidance to research project teams and therapeutic area teams including authoring regulatory strategy section of product development plans• Produced regulatory strategies for new drugs• Devised strategy for presentations to FDA of End-of-Phase II, authored briefing/background documents, and led face-to-face meetings with reviewing divisions• Developed and improved company-wide SOPs for regulatory compliance• Provided regulatory review and advice on requests for proposals and scopes of work for contract R&D• Assigned and assessed transfer of regulatory obligations for IND projects

• Led Regulatory Affairs for company and subsidiaries not including Animal Health• Responsible for preparation and assembly in eCTD format of 1 NDA for a new chemical entity, 2 505(b)(2) NDAs, and 1 NDA for 505(b)(2) product in a new drug-delivery device• Provided regulatory support for preparation and assembly of 2 505(b)(2) NDAs in eCTD format for new drug product formulations with partners.• Coordinated preparation and assembly of 6 successful original IND submissions for new chemical entities, a new combination drug, and new drug product formulations• Facilitated and supervised all communication with FDA for 16 approved and investigational products in the following divisions: o Cardiovascular and Renal Productso Neurology Productso Dermatology and Dental Productso Metabolism and Endocrinology Productso Anesthesia and Analgesia Productso Anti-Infective and Opthalmologic Productso Reproductive and Urologic Productso Pulmonary, Allergy and Rheumatology Productso Medical Imaging Products• Scientific leader of diverse team of scientists and was accountable for development of unique drug product technology with >$100 million budget• Led, managed, and responsible for Regulatory Affairs Department comprised of 20+ people in 4 offices, a multimillion dollar annual budget, 51 active NDAs, and 11 active INDs• Voting member of several company-wide committees including Executive Copy Clearance, Medicines Safety Board, Risk Management Team, Research Grant Committee, and Non-Promotional Executive Review Committee• Performed regulatory and clinical science assessments of over 25 due-diligence investigations per year for potential drug and device acquisitions

• Coordinated preparation and assembly of 3 large (>600 volumes) full NDA submissions, 2 supplemental NDA submissions for new indications, and 2 IND submissions for new chemical entities• Facilitated all communication with FDA for 3 investigational products in the following divisions: o Cardiovascular and Renal Drug Productso Medical Imaging and Radiopharmaceutical Drug Productso Over-the-Counter Drug Products• Led, coordinated, and presented before FDA Advisory Committees (OTC, Cardio-Renal, Gastrointestinal and Hematology, Rheumatology)• Coordinated preparation of "simultaneous" Marketing Authorization Application for European Medical Evaluation Agency• Led and coordinated communications with Therapeutic Products Directorate in Canada and European Agency for the Evaluation of Medicinal Products• Produced clinical development strategies for new drugs• Conceptualized, organized, authored, and edited new drug applications for simultaneous international marketing approval of unique medicines (USA, Europe, and Canada)• Devised strategy for presentations to FDA and EU of Pre-IND, End-of-Phase II, and pre-NDA plans• Authored expanded summaries, 5 ISSs, 3 ISEs of 4 NDAs, 2 sNDAs, and 2 MAAs as well as 4 application summaries and 2 expert reports• Led 2 large, diverse teams of medical scientists, clinical statisticians, non-clinical scientists, regulatory specialists, and QC staff as well as coordinated data and documents with clinical data management, regulatory affairs, chemistry and manufacturing, non-clinical departments, and drug information