Regulatory Affairs Assistant Manager
Kebutuhan ini untuk PT. Pertiwi Agung Landson (part of Mensa Group)
Jobdesc :
Bertanggung jawab untuk mempersiapkan dokumen registrasi sesuai dengan timeline penyusunan dossier yang telah ditetapkan
Bertanggung jawab submit dokumen registrasi dan berkomunikasi secara efektif dengan badan yang berwenang untuk mendapatkan persetujuan produk tepat waktu sesuai yang direncanakan.
Membina hubungan baik dengan BPOM, Kementerian Kesehatan dan institusi lainnya untuk memperlancar semua proses yang terkait dengan regulasi.
Memantau status registrasi produk, baik dari segi timeline registrasi maupun data-data yang tersedia.
Berkoordinasi dengan departemen lainnya untuk mendapatkan dokumen-dokumen yang dibutuhkan sesuai dengan deadline dan kelengkapan berkas
Requirement :
Pendidikan S1 farmasi dan profesi apoteker
Pengalaman kerja minimal 3 tahun sebagai Registration Officer atau Regulatory Affairs di perusahaan farmasi
Menguasai proses registrasi Obat, Suplemen, Obat Bahan Alam, Kosmetik, Alat Kesehatan, (New/Baru, Variasi, Renewal), Perizinan dan regulasi terkait Registrasi baik dari BPOM dan KeMENKES
Memiliki kemampuan berbahasa inggris, baik lisan dan tertulis dalam kapasitas professional (review dokumen dan rapat dalam bahasa inggris)
Bersedia melaksanakan dinas ke Badan Regulator seperti : BPOM / Kementerian Kesehatan/ etc
Penempatan di HO (Kuningan, Jakarta Selatan)
Profil perusahaan
Pharmaceuticals, Biotechnology & Medical Devices
The group of companies that is today known as MENSA GROUP started through the establishment of PT Menjangan Sakti by its founder - Mr. Jimmy Sudharta in April 1975. The company started its business in trading raw material for pharmaceutical industry throughout Indonesia. Within a short period, the company expanded its business and diversified its activity covering cosmetic, food and feed industries. Continuous growth of PT Menjangan Sakti, has provided the company ability and resources to expand in related business. Since 1981, PT Menjangan Sakti has started to acquire some companies and formed a group business known as Mensa Group. Now, Mensa Group comprises of several companies with diversified activity such as importing and trading pharmaceutical raw materials, food, feed and cosmetics; pharmaceutical manufacturing, medical supplies and dental equipment manufacturing; pharmaceutical' hospital / medical supplies, consumer goods distribution and healthcare service. The group employs approximately 6500 employees for running its business and established a solid distribution network throughout Indonesia as an asset for further growth. History The group of companies that is today known as MENSA GROUP started through the establishment of PT Menjangan Sakti by its founder – Mr. Jimmy Sudharta in April 1975. The company started its business by trading pharmaceutical raw materials throughout Indonesia. With time the company expanded its business and diversified its activity to include the cosmetic, food and feed industries. Continuous growth of PT Menjangan Sakti has provided the company the ability and resources to expand into related business. Starting 1981, PT Menjangan Sakti acquired several other companies in related activity including pharmaceutical manufacturing companies and Distribution Company, forming what is today known as Mensa Group. Mensa Group comprises of several companies with diversified activity such as: - importing and trading pharmaceutical raw materials including food, feed and cosmetics; - pharmaceutical manufacturing ; - medical supplies and dental equipment manufacturing; - Pharmaceutical, hospital / medical supplies, consumer goods distribution and healthcare service. The group employs approximately 6500 employees, and main aim in the near future is to establish a solid synergy between the companies and amongst other to develop a nationwide distribution network as an asset for further growth. Product & Services Mensa Group, comprises of several companies with diversified activity such as import, export and trading pharmaceutical raw materials, food, feed, and cosmetic; generic pharmaceutical manufacturing, medical supplies and dental equipment manufacturing, pharmaceutical; hospital/medical supplies, consumer goods distribution and healthcare service. This website will act as a portal that links to all the companies within Mensa Group.
The group of companies that is today known as MENSA GROUP started through the establishment of PT Menjangan Sakti by its founder - Mr. Jimmy Sudharta in April 1975. The company started its business in trading raw material for pharmaceutical industry throughout Indonesia. Within a short period, the company expanded its business and diversified its activity covering cosmetic, food and feed industries. Continuous growth of PT Menjangan Sakti, has provided the company ability and resources to expand in related business. Since 1981, PT Menjangan Sakti has started to acquire some companies and formed a group business known as Mensa Group. Now, Mensa Group comprises of several companies with diversified activity such as importing and trading pharmaceutical raw materials, food, feed and cosmetics; pharmaceutical manufacturing, medical supplies and dental equipment manufacturing; pharmaceutical' hospital / medical supplies, consumer goods distribution and healthcare service. The group employs approximately 6500 employees for running its business and established a solid distribution network throughout Indonesia as an asset for further growth.