Aljukhri R.
Senior Regulatory Affairs & Compliance Specialist
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About
Aljukhri R. is a seasoned Regulatory Affairs & Compliance professional with over 8 years of targeted expertise spanning the Medical Devices, Pharmaceuticals, Halal Certification, Cosmetics, and Food industries. Operating from Jakarta, Indonesia, he has demonstrated a solid track record in managing regulatory submissions for over 300 SKUs and has excelled in maintaining seamless compliance with Indonesian bodies such as KEMENKES, BPOM, and OSS-RBA. In his recent role as Regulatory & Compliance Lead at PT. Lynea Primisima, Aljukhri streamlined regulatory strategies to foster business expansion, notably securing Halal Certification for 13 product lines and leading SNI certification activities for 7 SKUs. His prior engagement with PT. Global Logistik Medika saw him enhance regulatory compliance for more than 200 medical device SKUs. Adept in establishing zero defects during audits, his capacity for cross-functional collaboration with international manufacturers reinforces market access and business continuity. Aljukhri's technical proficiency is supported by certifications in ISO 9001:2015, Good Manufacturing Practices, and Halal standards.
Experience
Regulatory & Compliance Lead – Medical Devices | Halal Supervisor
PT. Lynea Primisima · 2024 — PresentActed as Responsible Person (PJT) for Medical Devices, ensuring ongoing regulatory compliance and licensing for 160 active SKUs. Developed and executed regulatory and compliance strategies for Medical Devices, Cosmetics, Processed Food, Halal, and SNI-regulated products to foster business growth. Functioned as Halal Supervisor, successfully obtaining Halal Certification for 13 product lines through collaboration with certification bodies and manufacturers. Conducted halal audits at manufacturing sites in China to verify compliance with halal standards. Oversaw regulatory compliance and product registration for Medical Devices, Cosmetics, and Processed Food, achieving a 20% reduction in regulatory lead time. Handled OSS-RBA licensing and managed communication with regulatory authorities to facilitate business operations. Directed SNI certification processes for 7 SKUs, ensuring proper documentation and coordination with relevant bodies. Maintained readiness for audits and compliance through risk assessments and the application of Quality Management System (QMS) principles.Responsible Person (Medical Devices) | Regulatory Compliance
PT. Global Logistik Medika · 2023 — 2024Served as Responsible Person (PJT) for Medical Devices, ensuring licensing for over 200 active SKUs. Managed regulatory compliance, monitored licenses, and conducted mandatory reporting to adhere to Medical Device regulations. Supported unrestricted business operations by maintaining operational licenses and regulatory submissions. Developed and maintained regulatory documentation per CDAKB and other requirements. Contributed to Zero Major Findings during audits through thorough preparation and compliance checks. Aided in implementing compliance controls and initiatives for regulatory governance enhancement. Worked closely with stakeholders and regulatory authorities to resolve compliance issues effectively.Responsible Person (Medical Devices) | Regulatory | Warehouse Head
PT. Kebayoran Pharma · 2018 — 2023Acted as Responsible Person (PJT) for Medical Devices, ensuring ongoing compliance and licensing for over 300 active SKUs. Oversaw registration of medical devices and post-market surveillance to comply with Indonesian regulations. Led warehouse operations and distribution, ensuring compliance and operational readiness across 20 branches in Indonesia. Monitored inventory and coordinated stock distribution between central and branch warehouses. Maintained required regulatory documentation, supported audit processes, and ensured readiness for compliance checks. Collaborated with vendors and internal teams to address various regulatory and supply chain compliance matters. Supported compliance inspections to uphold a strong regulatory framework within business processes.
Skills & Expertise
Education
- Bachelor of PharmacyUniversitas Pancasila · 2011 — 2017