Dexa Group

Regulatory Assistant Specialist

Dexa Group  •  Banten, ID (Onsite)  •  23 days ago
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Job Description

  • Menyiapkan, meninjau, dan mengelola dokumen registrasi produk sesuai ketentuan otoritas regulatori setempat (lokal maupun overseas)
  • Mendukung proses submission untuk registrasi baru, perubahan, dan perpanjangan melalui sistem otoritas regulatori.
  • Memantau progres pengajuan dan melakukan tindak lanjut untuk memastikan timeline terpenuhi serta memberikan update kepada pemangku kepentingan internal.
  • Berkoordinasi dengan tim internal dan pihak eksternal untuk pengumpulan dan verifikasi dokumen teknis.
  • Memelihara database dan arsip dokumen regulatori agar akurat, lengkap, dan siap untuk kebutuhan audit.
  • Profesi Apoteker
  • Berpengalaman 1–2 tahun di bidang Regulatory Affairs (Alat kesehatan dan Produk Obat) diutamakan
  • Fresh graduate dipersilakan melamar
  • Memahami dasar-dasar persyaratan regulatori dan proses registrasi produk lokal maupun overseas
  • Memiliki kemampuan Bahasa Indonesia & Bahasa Inggris yang aktif
Dexa Group

About Dexa Group

Dexa Group has evolved from a small company established in 1969 to one of Indonesia’s largest ethical pharmaceutical companies at the beginning of the 21st century and has become a prominent, well-respected player in the domestic pharmaceutical market.

Providing better health care by applying expertise was the foundation on which its founders built this Company. Honesty, trust, dedication and commitment to providing patients with the highest quality of ethical pharmaceutical products and OTC are preserved as the guiding principles, based upon which the highly professional management team and the motivated, competent staff of Dexa Group have developed the Company in the spirit of mutual respect, teamwork and innovation over more than four decades.

Serving as a good corporate citizen is one of our responsibilities and being a strategic asset of Indonesia is one of our foremost desires. For along time Dexa Group has worked together with governing institutions and the Indonesian Pharmaceutical Association – championing compliance and improving the industry standards.

Ir. Ferry A. Soetikno, M.Sc., M.B.A.

(President Director)

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Dexa Group is always on the lookout for talented individuals who want to grow with us. If you are interested in becoming part of our team, please visit our career site at www.dexagroupcareer.com or follow us on Instagram @dexagroupofficial. You can find information about various job opportunities, more details on how to join our team, and glimpses of life at Dexa Group!

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Tangerang Selatan, ID
Year Founded
1969
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