REGULATORY AFFAIRS (SUPERVISOR) PT TRIO RASA MAS

JOB DESCRIPTIONS :

• Execute & monitoring registration process
• Coordination with related department and Principals, registration document request, review documents & prepare good registration dossier, do registration submission to BPOM/Kemenkes system, including additional data fulfillment, monitor & follow up the registration process until getting the approval (if needed negotiation with BPOM/Kemenkes)
• Ensure all regulatory activities (new product, variation & renewal submission) are comply with current regulations, requirements and practices.
• Ensure to get approval as committed timeline
• Liaise with Manager & Dept. Head to get advises on regulatory strategy and approach.
• Develop good relations with internal & external stake holders.

JOB REQUIREMENTS :

1. Has experiences in regulatory affairs min 3 years handling registration process for categories of processed food, medical devices, health supplement, cosmetics, traditional medicines & advertisement registration.
2. Knowledge of the local regulatory affairs environment and how this impacts regulatory strategy and implementation, especially related to product registration requirements, regulations & quidelines.
3. Strong interpersonal skills.
4. Detail-oriented with the ability to manage projects from inception through execution and tracking progress of projects to completion
5. Good communication & negotiation skill
6. Loyal & has a good responsibility, good teamwork
7. Positive attitude
8. Fast learning