Regulatory Affairs Specialist Job in Cambridge, Massachusetts US
Regulatory Affairs Specialist
Regulatory Affairs Specialist - JOB TITLE:Sr Associate I, R D Compliance Systems Job Responsibilities . Primary responsibility would include the execution and maintenance data entry, administrative reporting and archival of R D-wide assigned trainings and the coordination of clients to complete procedural requirements within the R D Training/Document quality system. . Additional activities include coordinating, in conjunction with the manager and other R D Compliance groups, the configuration and implementation of necessary R D Compliance training and document quality systems/technologies e.g. processes and toolsets . . Participates as a R D representative on relevant R D Compliance Systems teams. . Maintain and provide customized reporting based on client/project requests. . Assist with the development of training activities across several departments within a therapeutic area in collaboration with the clinical development SMEs and R D Compliance. . Integrate the scientific rationale, regulatory requirements and Quality Management System goals to build a solid strategic framework for the organization. . Develop and maintain relationships with counterparts within internal and external Departments. . Develop, design and maintain the development of the R D Compliance MS SharePoint Sites. . Acts as a technical resource for R D Compliance i.e. MS SharePoint Research Preclinical Development Qualifications Minimum Experience . 2-3 years biotechnology or pharmaceutical experience . 2 year s experience in compliance specialty function or equivalent experience/education . General understanding of GxP regulations and guidelines i.e., FDA and ICH Guidelines, government compliance programs . Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment. . Demonstrated strategic and critical thinking. . Excellent communication skills oral and written and excellent organ