dossier

DescriptionMemastikan bahwa seluruh dokumen produksi dan analisa rutin tersedia dan sesuai dengan yang diregistrasikan ke BPOM, termasuk di dalamnya kesiapan sistem Oracle atau LIMS atau infotehna. Merencanakan, memonitor, mengkoordinasikan, mengelola, mengevaluasi, dan mengkaji proses registrasi suatu produk, terkait dengan renewal, variasi, maupun...

International Beauty Products Ltd. in Jakarta is seeking a Pharma Registration Supervisor to lead regulatory activities for BPOM registrations.You will prepare and review CTD/ACTD dossiers and coordinate with BPOM to ensure compliant submissions and timely approvals. The role requires a Bachelor’s in Pharmacy, at least 2 years’ experience in...

PT. Elit Solusi Niaga is seeking a Regulatory Affairs Assistant to support the preparation and submission of product registration documents to government authorities in Indonesia.You will verify document accuracy, coordinate client materials, and respond to regulator requests while keeping teams updated on changes. The role requires a pharmacy-related...

This is a full-time, on-site position for a Pharma Registration Supervisor based in Jakarta. The successful candidate will be responsible for leading and coordinating pharmaceutical product registration activities to ensure full compliance with BPOM regulations and applicable standards. The role includes preparation and review of regulatory dossiers,...

Arbex in Jakarta is seeking a Regulatory Affairs Associate to manage halal registrations and liaise with authorities to support local and regional objectives. You will oversee halal strategy, audits, and dossier preparation while collaborating with marketing and manufacturing teams.The role requires a pharmacy/technical degree and 1–5 years of regulatory...

PT Biomedikal Scientific Indonesia in South Jakarta seeks a Registration Officer / Regulatory Affairs to manage medical device registrations and regulatory dossiers with the Ministry of Health and related authorities. The role requires a Bachelor’s in a science field, strong English, and knowledge of CDAKB Internal Audit and E‑Report/OSS systems.You will...

PT SKPLASMA CORE INDONESIA, part of SK Group, seeks an experienced regulatory affairs specialist to manage BPOM registrations, re-registrations, and variations for biopharmaceutical products. You will be the main regulator liaison, preparing dossiers and ensuring compliance across BPOM, Ministry of Health, and related local authorities.The role involves...

Medtronic recherche un spécialiste pour assurer le support technique sur site lors de l’installation et de la maintenance des produits, et pour veiller à la traçabilité des dossiers et des systèmes. Le rôle prévoit la planification des effectifs afin de répondre rapidement aux situations critiques et garantir le fonctionnement conforme.Vous...

PT. Daewoong Pharmaceutical Indonesia is seeking a Market Access Manager to lead centralized hospital-group and national-institution listings.You will drive strategic account prioritization, mapping, dossier preparation, pricing, tendering, and activation across major healthcare institutions and committees. You will manage relationships with headquarters and...

ARBEX is seeking a Regulatory Affairs professional to lead halal registrations and liaise with BPJPH and other authorities. You will ensure compliant dossiers, manage audits, and collaborate with manufacturing and marketing teams to support growth.Ideal candidates have a pharmacy/technical degree, 1–5 years in regulatory affairs, and strong English and...

Qualification: a)        Bachelor’s degree in electrical/physics engineering (S1) from  university.b)        Minimum 10 years experiences in relevant instrument subsea and offshore commissioning upstream oil and gas facilities topside facilities.c)        Experience with relevant international codes and standards: DNV, ISA, FCI, API, IEC,...

Qualification: a)        Bachelor’s degree in electrical/physics engineering (S1) from  university.b)        Minimum 10 years experiences in relevant commissioning upstream oil and gas facilities topside facilities.c)        Experience with relevant international codes and standards: DNV, ISA, FCI, API, IEC, NEMA, ASME, AGA, ISO, ANSI and...

KATENE recrute une Assistante d’Agence pour le Bureau d'Études Fluides et Thermique en CDI 80%, basé à Meyreuil (Aix-en-Provence). Vous assurez l’assistance administrative/financière et soutenez les collaborateurs de l’agence selon les besoins quotidiens.Maîtrise des outils bureautiques et une forte capacité d’organisation et de communication...

Qualification: a)        Bachelor’s degree in electrical/physics engineering (S1) from  university in Indonesia. b)        Minimum 8 years experiences in relevant instrument pre-commissioning and commissioning upstream oil and gas facilities c)        Experience with relevant international codes and standards: ISA, FCI, API, IEC, NEMA,...

Qualification: a)        Bachelor’s degree in electrical/physics engineering (S1) from  university.b)        Minimum 10 years experiences in relevant commissioning upstream oil and gas facilities topsidec)        Having experience working in FPU/FPU/FLNG and brownfield projectd)        Familiar with relevant international codes and...

Qualification: a)        Bachelor’s degree in electrical/physics engineering (S1) from  university in Indonesia. b)        Minimum 10 years experiences in relevant instrument pre-commissioning and commissioning upstream oil and gas facilities topside facilities.c)        Familiar with relevant international codes and standards: ISA, FCI,...

Qualification: a)        Bachelor’s degree in electrical/physics engineering (S1) from  university in Indonesia. b)        Minimum 10 years experiences in relevant instrument pre-commissioning and commissioning upstream oil and gas facilities topside facilities.c)        Experience with relevant international codes and standards: ISA, FCI,...

Mega Lifesciences is seeking a Regulatory Affairs Executive for Export to work with the Regulatory Affairs Manager in a fast-paced environment. Responsibilities include preparing and managing English dossiers and coordinating submissions with destination authorities.The ideal candidate has a pharmacy degree and 2–3 years in regulatory affairs, with strong...

The agency is looking for a Freelance Sales Agent to manage the German-speaking (DACH) and English-speaking markets, based on-site in Bali for the first year, with the role potentially evolving into a hybrid setup afterward, provided physical presence continues during the high season. You will handle traveler requests from first contact through to the design...

Product Development (R&D): Overseeing new product formulas, pilot trials, and improving existing products. Quality Control (QC): Testing raw materials, packaging, and in-process control (IPC) to ensure quality standards. Regulatory Compliance: Ensuring compliance with BPOM, GMP/CPOB, ISO 9001, or ISO 17025 standards. Laboratory Management: Managing lab...