Regulatory Affair Manager

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