Regulatory Affair

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