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-time
Contract length: 48 months

**Salary**: Rp45,000 - Rp50,000 per hour

Expected hours: 80 - 120 per week

**Experience**:

- Pharmaceutical Regulatory Affairs: 8 years (required)
- Medical Devices Regulatory Affairs: 3 years (required)