Lowongan Regulatory Staff di PT Etana Biotechnologies Indonesia

• Manage and support the process of administrative activities, both form filling documents and others.​
• Coordinate with the plant team & principle to fulfill all documents which needed for product registration (local or import) as appropriate to the requirement​
• Support the preparation of submission and/or renewal of the GMP Certificate to NADFC, as well as coordinating with the plant team if there are deficiencies or questions requested by NADFC​
• Review, submit, and discuss with Indonesian FDA during registering products (NCE, Biological, Biosimilar, Vaccines)​

Requirements

• Must have Bachelor’s Degree in Chemistry, Biology, or related field (preferably Pharmacy)
• Have min. 1 year of professional experience as Regulatory Staff in Pharmaceutical Industry​
• Fresh Graduates are welcome to apply​
• Excellent skills in prioritizing, problem solving, organization, decision-making, persuasion, time management and planning​
• Fluent in English (Both written and verbal) ​
• Willingness to work with overtime in needed ​
• Able to work independently and within a complex team environment​
• Willing to be stationed in East-Jakarta​