Cardinal Health Scientist III, Chemistry, Mfg & Cntrl in San Diego, California
What Regulatory Sciences contributes to Cardinal Health
For over four decades, our industry-trained regulatory consultants have provided expertise and guidance to help pharmaceutical, biotechnology, and medical device companies get their products to market. Our regulatory and product development strategies are designed to reduce the risk of failure and increase financial returns on your research investments. We provide efficient scientific and regulatory consulting services throughout the full product life-cycle to help ensure the continued success of your product post-approval.
What is expected of you and others at this level in Research for functional success
• Demonstrates in-depth knowledge of respective scientific discipline and familiarity with related scientific disciplines
• Develops and implements detailed experimental plans for non-standard situations
• Provides guidance to other junior Scientists and may supervise direct reports
• Leads the innovative efforts and advancing the organization’s intellectual property within own projects
• Present and publish research findings in conferences and peer review journals
• Directly interfaces with customers on a regular basis
• Supports business development activities
• Works to understand customer needs and makes recommendation
• Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces
• Using the client's templates for dossier sections, author CMC sections for routine submissions (e.g., clinical trial amendments, Type I variations, IND/NDA/BLA annual reports, CMC renewals), including adding technical data and descriptive text
• Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and
• Demonstrates deep customer expertise; collaborates with appropriate parties to identify the drivers leading to business success.
• Encourages informed risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources.
• Proactively develops and maintains technical knowledge in specialized area(s), remaining up to date on current trends and best practices
• Manages assembly of regulatory information for submission
• Adheres to the client's defined submission preparation timelines
• Searches document and change management databases for historical data/information that need to be captured in the updated regulatory submission
• Collaborate with Data Verification Specialist to have submission content verified
• Liaise with Senior Submission Preparation resource to have work product reviewed
• Bachelor's degree required, PHD preferred
• Minimum 2 years related experience authoring CMC sections for routine submissions in pharmaceutical and/or biotechnology and/or medical device.
• Foundation in general scientific practice and in the principles and concepts of a discipline (e.g., chemistry, pharmaceutical science, pharmacy, biology, microbiology etc.)
• Sound knowledge of several aspects of regulatory principles, practices and concepts applicable to preparing regulatory submissions
• Rudimentary understanding of drug development or manufacturing/improvement processes
• Understands regulatory merits for scientific/technological development or manufacturing activities
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.