Responsible for all Regulatory Information Management and Records Management activities for the DS Regulatory West Development business. Operates as the Regulatory Information Management expert.
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Leadership of the Regulatory Information Management function which includes driving establishment of Regulatory Processes and Systems to deliver all RIM and EDMS Systems and solutions; Regulatory Services providers to deliver authoring and publishing of Regulatory submission packages. Partner with all appropriate company units – Regulatory Development, Labeling and Marketed Product teams.
Responsible for maintenance and development of business processes related to registration management data flow. Identify and initiate on-going continuous process improvement opportunities with end users responsible for data entry and/or data consumption. Collaborates with the business to ensure that the system effectively enables regulatory business processes. Works with other functional areas to solve problems while considering regulatory requirements and other functional area perspectives.
Ensure records management strategies are aligned with compliance and inspection readiness requirements and priorities. Ensure key business partner’s records management requirements are well-defined and expectations met. Manage response and reconciliation of internal and external audits.
Responsible for the identification and implementation of initiatives within the RM portfolio of work.
Working in partnership with functional leads and the Records Management staff, assure appropriate prioritization and allocation of resource to accomplish shared RM goals. Responsible for 1-5 direct reports at varying levels of responsibility.
Maintain current knowledge of existing and emerging health authority regulations and programs as well as short- and long-term organizational goals; develop and maintain roadmap for evolution of GRA systems and processes to enable these.
Participate on GRO Sub-Committee leadership team to set and drive direction of RIM organization. Chair Regulatory Information Optimization Global WS.
Qualifications:
Bachelor's degree in computer science, management information systems, or related field preferred or equivalent combination of education and experience.
10+ years in the Pharmaceutical industry, 5+ years direct experience with Regulatory Affairs
Demonstrated leadership of significant cross-functional or global system and process implementation.
Demonstrated information management and understanding of the drug development environment.
Strong understanding of current and emerging technologies designed to enhance DSI’s business processes and practices.
Experience and facility in working in a multicultural, multidisciplinary global environment.
Demonstrated leadership in the management of staff and projects.
Strong interpersonal skills.
Strong oral and written communication skills.
Strong analytical and problem solving skills.
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