Lowongan Regulatory Affairs di PT Ous Utama Indonesia

Job Description :

• Manage the whole process of product registration, including but not limited to compiling their required documents, review the documents to check the sufficiency of the content with the local requirement, dossier preparation and submission to related Health Authority, follow up until the licence is approved within the expected timeline.
• Manage preparation artworks of packaging for new products and artworks change of exiting products.
• Ensure labelling/ artwork of packaging for products are comply to the company packaging guidelines and the local authority requirements/ product approval.
• Manage regulatory compliance of all product component (raw material, composition, manufacturing process, specification and packaging).
• Manage renewals and variations applications for existing products
• Taking care of regulatory assessment (regulations/ registration requirements, key documents for registration, patent and trademark if needed).
• Ensure finished product manufactured comply to the product approval.
• Interpret the need of and providing information/ additional data or corrections required by the local Health Authority.
• Monitoring and setting timeline for filling submission and approval.
• Able to act as regulatory advisor to R&D and manufacturer and RA colleague in other country
• Approve promotional and advertising material from regulatory standpoints as appropriate
• Develop and maintain good and professional relationship with appropriate regulatory agencies to ensure smooth and efficient registration process
• Interface with Business Development Director in order to ensure regulatory strategies and processes are in line with local business strateg
• Participate in development of procedures and processes ensuring that they are compliant with local laws and regulations
• Monitor regulatory status, change control, and providing monthly progress report
• Any other related duties as may be assigned

Requirements :

• At least a Bachelor’s Degree or Post Graduate Diploma in Food Science / Technology / Nutrition or equivalent from accredited institutions of higher learning or higher.
• At least 5 years of Science & Regulatory Affairs relevant working experience in food / FMCG industry.
• Sound and updated knowledge on Asian Region product regulatory requirements would be an added advantage.
• Excellent written and verbal communication skills (Bahasa & English)
• Ability to speak Mandarin language could be an added advantage to deal with stakeholders.