Regulatory Affairs Manager Jobs

Requirement:

• Willing to be placed in Cikarang
• Experienced in the process of registration of cosmetics, supplements, medical devices, PKRT
• Advance in building relationship with BPOM and the Ministry of Health
• Excellent written and verbal communication skills (Bahasa & English)
• At least 10 years of Regulatory Affairs relevant working experience in Pharmaceutical Manufacturing industry.
• Minimum bachelor degree in Apothecary

Role and responsibilities:

• Taking care of regulatory assessment (regulations/registration requirements, key documents for registration, patent and trademark if needed).
• Follow up and monitor the product registration process
• Make a request for registration documents to the Principal for export/import product
• Manage renewals and variations applications for existing products
• Manage regulatory compliance of all product component (raw material, composition, manufacturing process, specification and packaging).