Job Description - Develop and implement regulatory strategies for ethical drugs, infusion products, and enteral nutrition. - Ensure full compliance with BPOM, Ministry of Health, and other relevant authorities. - Oversee product registration processes before market entry. - Manage documentation and submission for new product approvals and renewals. - Act as the primary liaison with BPOM, Kemenkes, and other regulatory channels. - Represent the company in regulatory meetings and industry forums. - Work closely with R&D, marketing, supply chain, and finance teams to ensure regulatory alignment. - Support product research and development from a regulatory perspective. - Lead and mentor a team of 5 regulatory professionals. - Ensure team performance, development, and regulatory knowledge are up to date. - Develop and maintain internal systems for regulatory tracking and approval workflows. - Ensure efficient handling of inactive product menus and approval systems. - Other duties as assigned.Job Requirement ・Bachelor's degree. ・10 years of experience as Regulatory Affairs from MNC pharmaceutical industry. ・Business level English proficiency. ・Proven experience engaging with BPOM, Kemenkes, and other regulatory bodies. ・Strong understanding of product licensing, compliance, and market entry processes.
