Regulatory Affairs Specialist

Role Overview Supports and responsible for product life-cycle management and ensures compliance of product portfolio with country health authority regulations. Reviews technical and regulatory documentation for regulatory filings e.g. product submission and approval. Acts as the liaison between company and local health authority/government. General Roles & Responsibilities Evaluate current and new products to ensure compliance with country regulations and company policies Create and implement compliance strategies for newly developed products. Ensure on-time renewals and life-cycle management actions, as appropriate. Support internal organizational audits, and organizational/functional regulatory work processes Keep abreast of any changes in the regulatory landscape, and provide assessment on possible impact to business Support and maintain an electronic or hard copy filing system for organizational records, as applicable. Support requests from customers or third-party vendors Work with cross-functional stakeholders, and health authorities to ensure the creation and delivery of compliance-oriented customer services. Evaluate product labels/ artworks, marketing and promotional materials to ensure compliance with applicable regulations and standards. To adhere to regulatory policies and GxP Qualifications Role Requirements Bachelor's degree or equivalent in Pharmacy or related discipline Must be knowledgeable of local Health Authority regulations and international standards and global regulations Good interpersonal skills Excellent oral and written communication skills Exposure to Project Management Knowledgeable in using business applications, such as word processing, presentation, and electronic mail Primary Location Philippines-National Capital-Manila- Organization Johnson & Johnson (Philippines) Inc. (8385) Job Function Regulatory Affairs Requisition ID 2206018582W