Registration Manager

5 days ago

Tangerang, Banten, Indonesia Private Advertiser Full time 900,000 - 1,200,000 per year

Duties

  1. Regulatory Research & Compliance: Investigate regulatory requirements for obtaining licenses (e.g., IDAK, CDAKB) in Indonesia, including business scope, facilities, personnel qualifications, and permits. Coordinate with management to prepare documentation, audits, and submissions to authorities to secure licenses on schedule.

  2. License Holder Selection: Evaluate potential local license holders (AKL) to assist in selecting suitable partners.

  3. IVD/Medical Device Registration: Collaborate with the Quality & Registration team to draft regulatory documents (aligned with BPOM requirements), submit registration applications, and secure product approvals. Manage post-market product maintenance.

  4. Local Facility Setup: Research legal requirements for establishing local manufacturing facilities (e.g., company registration, environmental permits, CPAKB, import licenses). Coordinate site selection, factory setup, and permit applications.

  5. Registration Strategy Execution: Develop registration strategies for IVD/medical devices (AKD) in compliance with Indonesian regulations. Coordinate cross-departmental activities (R&D, production, clinical trials) to prepare and submit registration dossiers to BPOM.

  6. LKPP E-Catalogue Compliance: Manage submissions to the LKPP E-Catalogue platform. Plan and calculate localization requirements (TDKN) to ensure products meet government procurement criteria.

Qualifications

  1. Education: Bachelor's degree or above in pharmaceutical science or related fields, or licensed pharmacist, that can be qualified as PJT for IDAK. Proficient in Verbal and Written English.

  2. Experience: Minimum 3 years in IVD/medical device registration. Proven track record of successful product registrations.

  3. Regulatory Expertise: Deep familiarity with BPOM and Indonesian Ministry of Health regulations. Established communication channels with regulatory authorities.

  4. Technical Knowledge: Proficiency in AKL (local license holder) and AKD (local manufacturer) registration processes, including facility setup and permits. Understanding of requirements for importing vs. locally manufactured products entering the healthcare system.

  5. LKPP Platform Skills: Experience with LKPP E-Catalogue submissions and TDKN (local content) compliance.

  6. Preferred Qualifications: Prior experience in AKD facility setup and registration.

Genetron Health is a leading precision oncology platform company in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment. The Company has developed a comprehensive oncology portfolio that covers the entire spectrum of cancer management, addressing needs and challenges from early screening, diagnosis and treatment recommendations, continuous disease monitoring and care, as wells as biopharma development services. Genetron Health offers customized services and products. The ultimate goal is to defeat cancer.

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