Lowongan Regulatory Staff di PT Dch Auriga Indonesia

Responsibilities:

• Do the Registration to BPOM and Ministry of Health (MoH) in terms of New Products, Variation and Renewal Submission
• Managing preparation of supportive data for BPOM/ MoH confirmation on New Products, Variation and Renewal Submission in order to obtain approval in timely manner
• Checking BPOM/ MoH label for regulatory submission and commercial production
• Managing internal audit to comply BPOM/ MoH regulation and provide corrective and preventive action of BPOM/ MoH audit finding
• Arranging completeness Product Information Files for New Products, Variation and Renewal Submission
• Handling BPOM/ MoH claim warning letter
• Responsible for preparing the document for Halal Certificate and others.
• Any other regulatory related matters
• Importation letter approval from BPOM.

Requirements:

• Apothecary
• Experience: having minimum 2-3 years in Regulatory Roles
• Having valid STRA
• Full Time (not affiliated with other institution or organization)
• Active speaking and writing in English