Regulatory Affairs Supervisor

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 : 

- 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.- Knowledge of the local regulatory affairs environment and how this impacts regulatory strategy and implementation, especially related to product registration requirements, regulations & quidelines.- Strong interpersonal skills. - Detail-oriented with the ability to manage projects from inception through execution and tracking progress of projects to completion- Proficiency in English both, written and spoken- Good communication & negotiation skill- Loyal & has a good responsibility, good teamwork- Positive attitude- Fast learning

Information :

• Company : Darya-Varia Laboratoria
• Position : Regulatory Affairs Supervisor
• Location : Jakarta Selatan
• Country : ID