Principal Scientist, Chemistry, Manufacturing & Controls (Director of Regulatory Affairs)

At Cardinal Health, we're developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities.

Function:
 Regulatory Sciences
Family:  Chemistry, Manufacturing & Controls (CMC)

What Chemistry, Manufacturing & Controls contributes to Cardinal Health
 

Comprehensive consulting services to clients on pre-approval and post-approval chemistry, manufacturing, and control aspects of Rx and non-Rx products. Our service ensures compliance with health authority regulatory requirements; we may be called upon to perform compliance and gap closure audits, interact with the Health Authorities on all aspects of manufacturing, testing and auditing of products, and provide client recommendation of manufacturer/vendor to produce product. We propose strategy to global knowledge sharing of information including discussions/presentations industrywide.


What is expected of you for success in your role

  • Consult with clients on pre-approval and post-approval chemistry, manufacturing, and control (CMC) aspects of Rx and non-Rx products.  Provide guidance and assistance to clients regarding strategies, research challenges, issues, concerns, and questions associated with the drug development process and chemistry, manufacturing, and controls issues. Prepare and data verify regulatory CMC documentation. Communicate effectively with clients, scientific colleagues, and worldwide health authorities. Collaborate well with internal and external stakeholders in achieving project goals.   
  • Use experience and knowledge to develop strategies to streamline the development and approval process for new products and for changes in existing products.  Must have a solid foundation of pharmaceutical knowledge.  Interact with subject matter experts and regulatory authorities, as required on technical and/or regulatory matters.  Demonstrate expert knowledge and understanding of relevant scientific, regulatory, and compliance areas.
  • Proactively identify potential issues, analyze options and provide recommendations to internal and external stakeholders. Understand and support the nature of our business and our company’s commitment to quality and responsiveness. Work with business development to prepare customer-specific proposals. 
  • Encourage informed and creative options to solve problems.  Create business opportunities, while maximizing existing resources.  Complete projects on time and within budget. Demonstrate leadership in both project and people management. 


What is expected of you and others at this level

  • Apply advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
  • Participate in the development policies and procedures to achieve specific goals
  • Recommend new practices, processes, metrics, or models
  • Work on or lead complex projects of large scope
  • Provides solutions which may set precedent
  • Act as a mentor to less experienced colleagues

Accountabilities in this role

  • Author and review regulatory documentation, primarily CMC documents, for INDs, NDAs, ANDAs, BLAs, Drug Master Files, and other  global regulatory applications/submissions
  • Write, review, and assess documentation based on sound scientific principles and  the phase of the development.
  • Provide advice, guidance, oversight, and/or develop regulatory strategies for CMC product development programs• Author and reviews documents associated with global pharmaceutical product development
  • Maintain good client relationships; consistently deliver high quality services within the agreed upon timelines.
  • Ensure an established level of billable hours per fiscal year


Qualifications

  • Ph.D. preferred or MS/BS in chemistry or a pharmaceutical-related science.
  • Ph.D. with 7 years or MS/BS with more than 10 years’ experience in support of pharmaceutical product development and/or CMC regulatory affairs.
  • Good understanding and application of scientific principles and techniques used in pharmaceutical product development.
  • In-depth knowledge and experience with cGMP requirements and ICH guidances.
  • Experience with drug product and formulation is preferred.
  • Experience with writing US and/or global regulatory applications in eCTD format.