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