The Everest Group


*A division of The Everest Search Group, Inc., Los
  Angeles, CA
*The Everest Search Group Inc., Lake Tahoe, NV

Ranked Top 200 of America's Best Executive Search Firms in 2017 by Forbes

Vice President Global Regulatory Operations 


COMPANY
Our client is an innovative leader in the U.S. biopharmaceutical industry with more than 1,000 employees throughout the United States & a diversified product portfolio focusing on a variety of therapeutic areas including Neurology, Immunology, and Oncology. 

LOCATION: MA

KEY ACCOUNTABILITIES 
• Create, develop and manage globally an organization which provides a state of the art and consistent high quality infrastructure service to entire organization and CHC functions for the strategic and operational management of all regulatory documents, submissions and archiving across the product lifecycle.
• A key aspect of the role is the development of a strategic plan for implementing technologies supporting all current and future authorities’ requirements globally, and ensuring consistency of standards in systems and processes in regulatory affairs.
• The position provides the SVP GRA & QA with an expert vision on regulatory informatics & submissions, which will have a positive impact on any application relating to marketed products or critical development projects for the business.
• The position must ensure that strategically, the organization remains a top player in the field and participate in the development and implementation of industry standards

FINANCIAL DIMENSION 
• Plans the budget and controls the costs of the Dossier and Document Management department
• As a system owner for all regulatory IT systems and the company electronic document and submission management systems, plans the budget and controls the costs of the IT systems

STRATEGIC IMPACT 
• Builds, leads and maintains a global organization that is customer driven by business needs of all countries
• Ensures the timely creation and submission of high quality, ‘Right First Time’ dossiers simultaneously in the regions and countries defined by the project-specific regulatory strategy and respective specifications.
• Oversees electronic and paper archival of all submissions, ensuring the physical integrity and accuracy of all documents
• Defines and oversees implementation of Dossier and Document Management strategies as well as strategies related to regulatory IT landscape and regulatory information
• Develops and utilizes state of the art Electronic Submission capabilities
• Identify, develop and implement outsourcing opportunities
• Provide management with expert opinion in the area of expertise and responsibility
• Defines strategic and forward thinking approach to achieve global consistency in regulatory standards and compliance aligned with business objectives and ensures that they are met
• Ensures that a system for management of GRA QD is available
• Defines and tracks a system of KPIs to monitor compliance in the area of GRA
• Ensures consistency and quality of global regulatory data and information and oversees generation of relevant analyses and reports
• Analyses and disseminates information on new developments and technologies; develops strategies to meet these and drives implementation as appropriate
• Proactively identifies global capabilities and capability enhancements required by the company, and works to develop strategies and business cases for funding, development and deployment
• Defines strategies to achieve global consistency in standards of employed systems aligned with business strategies and ensures that they are met
• Oversees the portfolio of information systems which are required to meet the needs of the global regulatory affairs organization
• Oversees governance for all regulatory systems as well as the company electronic document and submission management systems
• Leads and manages the design and delivery of an integrated regulatory document management and publishing system
• Leads and manages the design and delivery of the company electronic document and submission management system
• Leads and mange the continuous improvement of the Regulatory database, oversees quality of the information, ensure adequate reports are provided to all stakeholders and define appropriate IS connections with other company and agencies systems.
• Is accountable as system owner for all regulatory IT systems as well as the company electronic document and submission management system

SCOPE OF PEOPLE RESPONSIBILITY 
• Develops functional area resources, including recruitment, deployment, professional development, and performance evaluation of employees
• Hire, manage staff and deploy resources as required to maintain and further develop the business
• Creates an environment that attracts, develops and retains high quality employees
• Maintains adequate staffing levels to meet resource needs
• Ensures adequate training and mentoring of employees
• Approves hiring of direct reports in all locations
• Serve as interface key contact with IT management
• Serve as interface with co-development or marketing partners when applicable
• Oversees cross-functional project teams in delivering critical global submissions and implementing strategic IT projects
• Builds strong relationship to entire organization and CHC functions
• Maintains strong collaboration with IT partners
• Ensures high quality interface to external vendor and oversight of vendor dossier and submission management activities
• Represents GRA on selected key company projects and relevant company committees
• Leads internal efforts and participates in discussions with health authorities on matters like electronic submissions and other regulatory IT-topics
• Encourages a high profile interface with associations and external groups to increase the company’s influence and ability to take advantage of a changing regulatory environment

REQUIREMENTS


EDUCATION
• Advanced degree in a scientific or technical discipline

WORK EXPERIENCE 
• At least 9 years experience in pharmaceutical or IT industry, thereof 4 years of regulatory experience
• Thorough understanding of the Regulatory Affairs area, including process and technology solutions
• Demonstrated experience with Health Authorities and related agencies

JOB-SPECIFIC COMPETENCIES & SKILLS  
• Fluent command of spoken and written English
• Demonstrate Ability to understand, manage and lead in a multi-cultural atmosphere, with an employee base that is distributed globally
• Proven leadership and management skills with cross-functional teams, as well as inspiration and motivation skills.
• Excellent interpersonal communications, organizational, and presentation skills.
• Superior negotiation and influencing skills
• Demonstrated experience with budgeting and planning.
• Strong leadership, strategic orientation, project management, development of people, and process improvement abilities in such a way that impact on business is substantial as it relates to submission management and follow-up.

COMPENSATION

• Base salary
• Bonus
• Long-term incentive plan
• 401k match
• Full relo










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