Regulatory Affairs (International)

DESKRIPSI PEKERJAAN

Requirements:
  • Candidate must possess at least a Bachelor's Degree, Pharmacy/Pharmacology or equivalent from the reputable university with GPA min 3,00
  • At least 2 year(s) of working experience in Internatioanl Regulatory Affairs (for Export)
  • Age : 25-30 years old
  • Excellent communication skills,  Fluent in English both oral and writen
  • Responsible to generate regulatory strategies to support business strategies and market access
  • Applicants must be willing to work in Cipete Raya,Jakarta Selatan.
  • Preferably Supervisor / Coordinators specializing in Healthcare - Pharmacy or equivalent.
  • Full-Time position(s) available.
Responsibilities:
  • Ensuring that a company's products comply with the regulations of the MHRA
  • Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to; collecting, collating and evaluating scientific data that has been researched by colleagues
  • Developing and writing clear arguments and explanations for new product licences and licence renewals
  • Preparing submissions of licence variations and renewals to strict deadlines
  • Monitoring the development process related to the product under the exported product pipeline
  • Prepare the anual budget for regulatory department
  • Monitoring and setting timelines for licence variations and renewal approvals
  • Planning and developing product trials and interpreting trial data
  • Advising scientists and manufacturers on regulatory requirements
  • Negotiating with regulatory authorities for marketing authorisation
  • Maintains a profesional relationship with Health Authorities and players of similar insdustry
  • Act as project management officer to manage the compliance of the existing product with the approval from BPOM
  • Handle quality assurance compliance for overseas such as complaint, recall, return, inspection.
 
 
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Deskripsi Perusahaan

PT SidoMuncul is a leading traditional herbal industry in Indonesia, with its famous brands: Tolak Angin, KukuBima Energy, KukuBima Kopi Ginseng, SidoMuncul KopiJahe, SidoMuncul SusuJahe, and AlangSari Plus. Located in Semarang - Central Java, Indonesia, PT SidoMuncul equipped with modern and high technology machinery and laboratory facilities, including: Extraction Center, Chemistry Laboratory, Microbiology Laboratory, Pharmacology and Pharmacognosy Laboratory, and Waste Treatment Center.
 

Review ( PT Industri Jamu Dan Farmasi Sido Muncul, Tbk )

Pekerjaan cukup berat


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Current Employee
Gaji & Benefit
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Nilai & Budaya
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Pros

Banyak sekali yang bisa saya pelajari di sini, terutama mengenai bisnis. Produk sudah sangat terkenal di Indonesia, bahkan pengiriman produk sekarang sudah sampai luar negeri.

Cons

Lebih berat di pekerjaan dibandingkan dengan waktu istirahatnya. Pekerjaan pun cukup berat dan dibutuhkan ketelitian, sebagaimana bekerja di pabrik pada umumnya.