Bristol-Myers Squibb Company

Global Regulatory Business Capabilities Group Director

Location
Princeton, NJ, US
Posted
Apr 12, 2018
Ref
R1504401
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

The Global Regulatory Business Capabilities Group Director (GRBC GD) is the system owner for the Regulatory Information Management systems and the Doc Base/Authoring system. The GRBC GD has a broad view of regulatory capabilities already deployed, but also drives the selection and adoption of new regulatory information systems and improvements. This role partners closely with Information Technology and business customers.
  • Maintains comprehensive and expert Global knowledge of the regulatory business capabilities and requirements including:
    • Global regulatory standards and requirements,
    • Regulatory environment and industry approaches ,
    • BMS- implemented standards and conventions across R&D systems with respect to business uses and operations.
  • Proactively develops strategy and business plans to optimize the regulatory capabilities for BMS including:
    • Assesses internal and external capabilities to advise the business on best models and approaches to support the regulatory capabilities, and drives the business case for changes when required.
    • Evaluates data quality and metrics reports; Present recommendations and solution options to governance
    • Owns the development of short- and long-term goals for GRBC in alignment with the BMS R&D business objectives and other involved functional areas.
    • Escalate recommendations on issues or changes to governance boards for decisions, as needed
    • Maintains resource forecasting and allocation plans


  • Supports and guides GRBC team members to lead functional and cross functional teams for delivery and maintenance of system capabilities;
    • Communicates strategy and objectives clearly and sets standards for success.
    • Provides strategic guidance with regard to all aspects of the assigned regulatory systems and requirements including rules, and data quality expectations.
    • Maintains assigned regulatory systems and processes by:
      • Assures assignments and process for system updates and releases in concert with Information technology partners, advise on system enhancements to meet business requirements
      • Monitor system update progress, identify potential issues and implement corrective actions
      • Oversees vendor/contract negotiations and invoices.


  • Oversees compliance and quality for GRBC processes and systems .
    • Ensures communication of compliance issues to appropriate stakeholders, facilitates remediation and continuous improvement.
    • Provide support for internal audits, HA inspections and corrective action plans. Instruct others on inspection preparation.
    • Maintain system of regulatory domain data stewards and process/data owners to support quality and compliance.


Educational and experience requirements
  • Minimum is a BA/BS in a relevant scientific or technical field; 7+ years of relevant pharmaceutical industry experience ,
  • Demonstrates experience and understanding of the procedures and decision-making process of the Health Authorities.
  • Strong knowledge and experience with electronic submission standards and requirements such as eCTD, SPL, EVMPD, IDMP.
  • Able to instruct others on navigating content of Investigational and Marketing Application structure.
  • Firm, detailed knowledge and experience with computer systems in an R&D environment. Expertise in system validation, testing methods, GAMP guidelines and electronic records regulations (FDA Part 11 compliance). Possess the ability to evaluate user acceptance criteria.
  • Experience in dealing with internal customers and supervising external contractors.
  • Expert with desktop applications, R&D systems and all integration points with RIM systems. Easily capable with new software and procedures.
  • Strong understanding of technology trends in Regulatory information management.
  • Excellent command of English language, both written and oral. Strong presentation skills.