Deskripsi Pekerjaan

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.
  • 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.
 
 

Tentang Perusahaan

Why join us

VISI Menjadi industri jamu yang dapat memberikan manfaat pada masyarakat dan lingkungan MISI :

Address

Jalan Cipete Raya, Jakarta Selatan, DKI Jakarta, Indonesia

No. Telepon

021-7653535

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