Regulatory Affairs Manager

10+ years of regulatory affairs experience in the pharmaceutical and medical devices industry**Prior experience preparing and reviewing submissions to BPOM**- Experience in Submission of New Drug Applications, Generic Drug Applications, Medical Devices Registration- Experience in Post Marketing Maintenance, Lifecycle Management of Marketed Drugs and Devices- Experience in managing Health Authority Interactions and Negotiations- Experience in reviewing ad promo material, review labels, work with cross functional teams**Ability to work independently, take initiative and complete tasks to deadlines****Ability to work within a matrix team environment****Strong written and verbal communication skills with good attention to detail****Good organizational skills and demonstrates effective time management****Desire to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands****Job Types**: Contract, Part-timeContract length: 48 months**Salary**: Rp45,000 - Rp50,000 per hourExpected hours: 80 - 120 per week**Experience**:- Pharmaceutical Regulatory Affairs: 8 years (required)- Medical Devices Regulatory Affairs: 3 years (required)