Associate Director, Global Labeling

Otsuka Pharmaceuticals   •  

Princeton, NJ

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 241 days ago

This job is no longer available.

Responsibilities

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. 

Responsibilities
• 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

Qualifications

Basic Qualifications
• 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 OtherExperience
• 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.

2018-10208