Global Regulatory Affairs – Brand Management & Labeling Led advertising/promotional review and labeling activities for Oncology Business Unit. Product portfolio included biologics, Subpart H products and multiple Orphan Drugs. Experience included successful new product launch, and multiple new indication, formulation, and product presentation launches. Specific responsibilities included:• Led and facilitated Promotion & Advertising Review Committee (PARC) for four marketed products and liaison for all communication with the Office of Prescription Drug Promotion (OPDP)• Led & coordinated process for multiple OPDP advisory comment submissions for Subpart H (accelerated approval) product• Led US labeling review and approval process, including label negotiations with FDA, for Oncology Business Unit• Led creation, review and approval process for Company Core Data Sheets• Served as Regulatory representative for Social Media Working Group

Functioned as Regulatory Advertising & Promotion lead for products and disease awareness campaigns in the Behavioral Health and Renal Business Units. Responsibilities included regulatory evaluation of all proposed promotional material and serving as liaison for all communication with the Office of Prescription Drug Promotion (OPDP). Experience includes initial product launch and new indication launches, eMarketing (Social Media, iPad applications, Mobile applications), direct-to-consumer (DTC) television, payor and FDAMA Section 114 material..Other specific responsibilities included:• Lead and facilitated Medical, Legal, Regulatory (MLR) review committee for 3 brands at various times• Lead & coordinated process for multiple submissions seeking OPDP advisory comments• Reviewed advisory board concepts and content to ensure compliance with all applicable rules and regulations.• Participated in the development of a strategic reorganization (and accompanying training) of the Field Sales organization to meet evolving needs of physicians and patients.

Functioned as Global Regulatory Strategy lead for INTUNIV®, responsible for global regulatory strategy and all communication with FDA. Specific responsibilities included:• Regulatory representative on the INTUNIV Product Strategy Team• Lead & coordinated global regulatory team for INTUNIV to develop and execute global regulatory strategy, including US lifecycle management and European & Canadian regulatory filing strategies• Lead & coordinataed NDA approval for INTUNIV• Lead & coordinated cross-functional team in labeling negotiations with FDA for post approval label changes• Lead & coordinated cross-functional team to gain approval of Shire’s second Pediatric Investigation Plan• Lead & coordinated regulatory efforts to divestiture of a product from the ADHD portfolio• Previously functioned as U.S. Regulatory lead for two products in ADHD portfolio (DAYTRANA® and INTUNIV®), responsible for all communication and negotiation with FDA on any IND/NDA-related issues.