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Ringkasan Yukerja
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Hiring: Freelance Regulatory Licensing Consultant – Indonesia (Project-Based)
About the Company
Our client is a global healthcare company expanding its presence in Indonesia. The company provides patients with access to innovative medications, medical devices, and advanced therapies that may not yet be available in their local markets. With nearly 40 years of experience, they are now establishing a foreign-owned company in Indonesia to import and distribute pharmaceutical products and medical devices.
About the Project
We are looking for a freelance consultant with a proven track record of helping healthcare companies obtain BPOM and Ministry of Health (Kemenkes) licenses, to:
? Set up the foreign-owned company (PT PMA), including the deed of establishment, ministerial ratification (SK Kemenkumham), business licensing via OSS-RBA (NIB), KBLI selection, and tax registration (NPWP/PKP).
? Obtain the licenses required to import and distribute medical equipment, including the Medical Device Distribution Permit (IDAK), Good Medical Device Distribution Practice certification (CDAKB), and distribution permits (AKL) for imported medical devices.
? Obtain the licenses required to import and distribute medicine, including the Pharmaceutical Wholesaler Permit (PBF), Good Drug Distribution Practice certification (CDOB), and BPOM distribution permits for imported drugs and health supplements.
? Handle supporting permits and requirements, such as the Warehouse Registration Certificate (TDG), warehouse layout approval from BPOM, pharmacist person-in- charge (APJ) arrangements including STRA, SIPA and CDOB training, and routine e- reporting.
? Advise on the most time- and cost-efficient approach overall, e.g. the optimal sequencing of applications and the minimum warehouse, facility and personnel requirements to satisfy the regulations.
Requirements:
? Demonstrated experience obtaining BPOM and Kemenkes licenses for pharmaceutical and/or medical device import and distribution businesses, ideally foreign-owned (please share your relevant track record).
? Familiarity with PT PMA establishment and OSS-RBA licensing.
? Practical knowledge of CDOB / CDAKB, warehouse standards and APJ requirements.
? Ability to work independently on a project basis.
Engagement & Quotation
This is a project-based engagement. Interested consultants are requested to submit:
? An itemized quotation covering all professional fees and government fees (PNBP) for each license, with any excluded costs (e.g. laboratory testing, travel, notary fees) clearly indicated.
? Estimated lead times per license, the documents required from us, and a brief profile of relevant past projects and references.
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