RMC Regulatory Specialist

Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Organizes and maintains reporting schedules for new drug application and investigational new drug applications. Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope of complexity. Conducts searches of existing files for requested information. Maintains and archives all regulatory documentation. Assists with investigation and resolution of compliance problems, questions, or complaints received from other groups in the business, customers and regulatory agencies. Documents, organizes and distributes changes to department procedures and common resolutions. Maintains database of routine compliance issues. Keeps up to date with current and emerging compliance regulations and processes and provides input to project teams. Compiles and organizes data, documents, and reports for inclusion in responses to queries made by various regulatory agencies. Supports implementation of new or revised policies and procedures. Collects information for presentations used to communicate pertinent information to regulatory agencies. Researches local compliance requirements. Coordinates, compiles, and submits new drug applications, abbreviated new drug applications and investigational new drug applications to the regulatory agencies. Responsible for providing technical support by interpreting federal and local regulations as they apply to products, processes, practices and procedures. Qualifications Pharmacist / Medical Doctor graduates Having experienced in regulatory fields for minimum 2-3 years (from MNC would be preferrable) Fluent and outspoken in english Familiar with end-to-end regulatory matters (new drug, variations, and renewal submissions, etc) Familiar to maintain good relationship with BPOM Primary Location Indonesia-Jawa-Jakarta Raya- Organization P.T. Johnson & Johnson Indonesia (8150) Job Function Regulatory Affairs Requisition ID 2206056428W