Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy

Job Description Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Responsible for leading the Global Regulatory Product Team (GRPT), developing, and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST), and serve as the primary regulatory interface with AST and supporting teams. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product. Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products. Qualifications Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject. Required Experience: 5-7+ years regulatory and drug development experience. Proven 5+ years in a strategic leadership role with strong project management skills. Preferred Experience: 7-10+ years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan. Location: Preferred location is Lake County, IL

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