JobStreet Teknologi & IT Full Time

Regulatory Affair

Standard Biosensor Indonesia

Purwakarta, West Java Salary not disclosed Posted 1 days ago
Location Purwakarta, West Java
Salary Salary not disclosed
Job Type Full Time
Country Indonesia

Job Description

Full details about the role and requirements

Yukerja Summary

The Regulatory Affair role at Standard Biosensor Indonesia is curated from JobStreet (category Teknologi & IT). Note the work location (Purwakarta, West Java) before applying. Yukerja.com is not the employer — applications are handled on the official source site.

Qualification

  • Bachelor’s degree preferable in pharmacy (another major can apply)

  • Have experience min. 3 years in related field

  • Strong analytical skills and attention to detail

  • Fluent in English (spoken & written)

  • Have good computer skills

  • Willing to be placed in Purwakarta


Job Description

  • Ensure that all company products comply with applicable regulations and standards in both local and international markets

  • Have experience in managing permits (TKDN, CPAKB, AKD, Halal, OSS, etc)

  • Ensure timely product registration (new, extension and variation) and handle all regulatory issues with Ministry of Health RI (KEMENKES RI) and Halal

  • Update information about regulation and product registration

  • Compile and submit periodic reports and other required documents to regulators

  • Analyze the impact of regulatory changes on the company’s operations and products

  • Gather, review, and prepare documents for submission to regulatory authorities


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