Leads the process for content development and maintenance for labeling and labeling components. The ideal candidate will be results-oriented with concerns for quality and collaboration. They will demonstrate a high-level understanding of labeling content requirements, regulations and guidance in support of labeling strategies. May be assigned additional responsibilities as deemed necessary.
• Supervises direct and indirect report(s) or acts to ensure all labeling materials follow relevant laws and regulations.
• Analyses and interprets new regulations and guidances as well as monitors and determines the impact of the regulatory environment and applicable regulatory decisions affecting labeling.
• Plan and lead cross-functional labeling team meetings to discuss and develop label content for new molecular entities (NMEs), developmental and mature brand products.
• Establish global labeling and operational support for all local subsidiary labeling requests to fulfill and meet local health authority requests and deadlines.
• Ensure consistency of core company position(s) and scientific accuracy for all global labeling components (ROW, U.S. and E.U.) through active communication and collaboration.
• Moderate and liaise with subject matter experts based on functional area(s) to resolve labeling issues or meet regulatory/health authority timelines.
• Follows and formulates improvements to labeling policies, processes, quality, and system tools.
• Provide creative and innovative ideas to move the Global Labeling and Regulatory department to address current and future challenges
• PhD/MS/DVM/MD/BS in life sciences, scientific, or engineering field.
• 7+ years of relevant experience in pharmaceutical regulatory/labeling environment.
• Demonstrated ability to work with and manage people in a global, dynamic environment to deliver value-added results.
Knowledge, Skills and Other Experience
• Solid understanding of global labeling regulatory requirements and industry practice
• Broad knowledge of clinical, CMC preclinical and clinical pharmacology
• Excellent understanding of medical concepts and terminology
• Solid understanding of the structure and function of product labeling
• Fundamental understanding of the pharmaceutical industry drug development process
• Strong written and oral communication skills
• Good computer skills including experience with XML including SPL systems, MS Office: Word, Excel, PowerPoint, and Outlook and Adobe products
• Action oriented, customer focused, ability to manage workloads, set priorities, and have demonstrated the ability to build effective teams. Must be able to deal with ambiguity.
• Ability to generate problem solving innovative solutions and motivate others to be innovative.
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of maental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.