Regulatory Affairs Senior Specialist - OperationsPosted: November 15, 2009
Position Summary The Global Regulatory Affairs Operations Senior Specialist supports Pharmaceutical Regulatory Affairs efficient operations. Serves as the main point of contact for regulatory strategy documents, maintains the standards framework and training requirements, and liaises with technology for regulatory systems. Specific Job Duties ? Develop system requirements for regulatory technology to streamline workflow, minimize risk, and create standard platforms where possible ? Team with Bausch & Lomb and Regulatory Affairs groups in the implementation of IT systems and applications ? Maintain the Standards Framework, which defines who owns, maintains, and drives implementation of standards, policies, and procedures ? Plan and manage all activities related to training, including the development and maintenance of training strategy, plans, content and tools ? Facilitate communications between internal subject matter experts and training vendors and where appropriate, develop and deliver training (e.g., SOP training) ? Maintain training records in accordance with Bausch & Lomb policies and procedures ? Communicate training requirements to the Regulatory Affairs organization ? Partner with the Regulatory Policy and Communication Director to monitor internal and external influences and coordinate with impacted functions to modify existing standards, policies and procedures Technical Competencies ? Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle, including Development, Commercialization, and Operations ? Ability to influence and partner within Bausch & Lomb Regulatory Affairs and with cross-functional teams in a global pharmaceutical organization ? Knowledge of current and emerging issues and trends of the regulatory environment specific to IT ? Knowledgeable of regulatory requirements governing computer system controls ? Ability to team cross-functional organizations in the development and maintenance of standards, policies and procedures ? Knowledge of current and emerging issues and trends of the regulatory environment and ability to integrate such within the Regulatory Affairs training strategy Professional Competencies ? Demonstrated ability in analytical reasoning and critical thinking skills ? Strong capability to contribute to a team environment ? Strong business acumen and ability to see the business drivers outside of Regulatory Affairs ? Excellent communication skills; both oral and written ? Strong interpersonal skills with the ability to influence others in a positive and effective manner ? Demonstrated ability to contribute to a continuous learning and process improvement environment ? Capacity to react quickly and decisively in unexpected situations ? Focused ability to influence operational excellence and performance metrics Please refer to job code 750396 when responding to this ad.
|
