Job Description
Full details about the role and requirements
Yukerja Summary
The Regulatory Affair Manager role at Medisindo Bahana is curated from JobStreet (category Kesehatan). Note the work location (Central Jakarta, Jakarta) before applying. Yukerja.com is not the employer — applications are handled on the official source site.
Responsbility :
1. Generate and present business cases to managements for potential products to be launched in Indonesia market.
2. Evaluate applicable laws and regulations to determine impact on company activities.
3. Maintain up-to-date international testing standards, regulatory specifications, and approval standards for all major product categories, including human medical devices, pet medical devices & pharmacy.
4. Monitoring and control product registration.
5. Handling government institutions related to company business.
6. Compile documents and complete the entire process until the product is displayed on the LKPP Online E-Catalog system.
7. Responsible with import process and incoming items
8. Responsible with suppliers: products, business discussion, and forecast order
9. Review and create product license and review promotional material for compliance with applicable regulations and technical standards
10. Trading, sourcing and procurement of medical health needed by sales team
Requirements :
· Having an active Registration Certificate of Pharmacist is a must
· Bachelor’s degree (S1) relevant to job (Pharmacist are preferred)
· Smart, fast learner, hard worker, loyal, honest, and creative
· Have experience in healthcare business and registration process for minimum 4 years is preferred
· Proficient in English both spoken and written. Have skill to communicate with overseas supplier
· Able to handle trading (purchase and import process)
· Able to work by team and individual
· Can Join ASAP