Regulatory Affairs Specialist Jobs

Job Scope:

• Maintain the NIE validity period
• Handle product registration for cosmetic, health supplement, food to BPOM and prepare DIP (Daftar Informasi Produk)
• Create and ensure the product etiquette are match with BPOM (claim compliance, artwork check and approval)
• Stay updated on relevant regulations and guidelines issued by regulatory authorities
• Maintain strong relationship with all stakeholder
• Prepare and create all documents needed for Export (CFS) and Import (SKI)
• Make monthly report and also coordinate with another department

Requirements:

• Excellent communication and interpersonal skills to collaborate with cross- functional teams and external suppliers, negotiation and administrative skills
• Have a good knowledge in regulatory compliance, regulatory system (PKRT, BPOM, halal certification)
• Experience for handling & dealing with Government Agencies (audit, inspection)
• Preferably has experience in preparing documents of import and reports requested by Government Agency
• Willing to mobile for doing all regulatory needed
• Problem-solving skills and the ability to address compliances challenges effectively.
• Minimum experience of 3 years in handling Regulatory
• Strong project management skills, including the ability to manage multiple projects simultaneously.
• Minimum Bachelor Degree from Pharmacist or Science Field ( have STRA/STRTTK is a plus point)