Job Description

•Main responsibilities: -Check and monitor all aspects of GMP and related issues. -Ensured that all health and safety guidelines were followed. -Responsible for achieving production requirements. -Participate in the planning, carrying out and following up of inspections, audits and internal inspections within field of responsibility. -Ensure license to operate, GMP compliance and audit/inspection performance at manufacturing side. -Review and approve procedures for batch status assignment (Confirmation and certification). -Reviewing and approving the contents of all documents for marketing authorization based on the relevant regulations. -provide stage supports for registration and documentation of new products and overseas the regulatory officers in the process of registration. -Having the responsibility of managing all regulatory affairs as responsible pharmacist through MOH, key opinion leaders (KOL's), regulatory agencies and health care professionals with scientific and medical information relating to the value and correct usage of the products. -As the Regulatory manager should meticulously manage the regulatory affairs personnel to ensure timely registration and approval of new products in health authorities. This position requires well-established connection with MOH and often visiting the MOH officers for registration of new products or extension over the approval of current products. -As the Regulatory manager should oversee on the regulatory affairs tasks to ensure that all written documents, packaging, designs are accurate and adhere to the guidelines mandated by the applicable FDA. All educational, technical and promotion materials are reviewed by regulatory team should be approved by Medicine Department & RA director. -Development, periodic review, revision and implementation of SOPs and quality control unit instructions. -Effectively manages priorities in order to implement corrective and preventive actions. -Provides educational meeting supports and ensure that the marketing field peoples are adequately equipped with educational materials. -Handles drug safety, reviewing individual adverse event reports, aggregate adverse event statistics, and sometimes even talking with customers or KOLs about drug safety.