Deskripsi Pekerjaan
Informasi lengkap tentang posisi dan persyaratan
Ringkasan Yukerja
Lowongan Regulatory Affair di Standard Biosensor Indonesia kami kurasi dari JobStreet (kategori Teknologi & IT). Perhatikan lokasi kerja (Purwakarta, West Java) sebelum melamar. Yukerja.com bukan pemberi kerja — lamaran diproses di situs sumber resmi.
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