Senior Executive, QA Regulatory Affairs

Tangerang, Banten, Indonesia

Senior Executive, QA Regulatory Affairs

JOB DESCRIPTIONS

• Prepare and submit registration documents in compliance with applicable regulations to obtain product registration numbers (e.g., BPOM and Halal certifications).
• Verify documentation provided by clients or customers to support the BPOM product registration process.
• Represent the organization during BPOM audits and inspections related to product registration processes.
• Liaise with BPOM to address and resolve issues arising during the product registration process.
• Evaluate formulations from the R&D department to ensure compliance with regulatory requirements for submission to BPOM.
• Collaborate with internal departments to ensure products meet regulatory standards and coordinate activities related to the product registration process.
• Monitor and follow up on the registration process with BPOM through designated communication channels.
• Facilitate the provision of required information to BPOM and Halal certification bodies in coordination with relevant departments.
• Review product designs, Drug Information Pack (DIP) documentation, and related materials to ensure compliance with BPOM, Halal, and ISO standards.
• Handle the registration of SKI (Surat Keterangan Impor) and SKE (Surat Keterangan Ekspor) for export products.
• Conduct internal and external audits to ensure compliance with BPOM, Halal, and ISO 22000:2018 standards.
• Register products for Halal certification with BPJPH (Badan Penyelenggara Jaminan Produk Halal) and LPPOM MUI (Lembaga Pengkajian Pangan, Obat-obatan, dan Kosmetika Majelis Ulama Indonesia).
• Participate in Halal competency training to enhance knowledge and support the product registration process.
• Implement and maintain robust document control procedures in line with regulatory and organizational requirements.
• Create, review, and approve technical documents, including procedures, work instructions, and specifications.
• Ensure all documents are up-to-date, accurate, and easily accessible to authorized personnel.
• Distribute documents promptly and efficiently to relevant stakeholders.
• Enforce document access controls to safeguard confidentiality and security.
• Monitor changes and updates to documentation to ensure ongoing regulatory compliance.
• Track document expiration dates, ensuring timely updates or retirement of obsolete documents.
• Maintain comprehensive records of document history, including audit trails and revision logs.
• Conduct routine audits to verify compliance with document control procedures and regulatory standards.
• Prepare for and provide support during regulatory audits and inspections.

JOB REQUIREMENTS

• Able to work in Tangerang Banten.
• Bachelor’s degree in food technology, Food Safety, Biotechnology, Chemistry, or a related field.
• Certification in food safety management systems (e.g., HACCP, ISO 22000) is an added advantage.
• Minimum 3–5 years of experience in regulatory affairs, food safety, or quality assurance within the food and beverage industry.
• Proven track record of managing BPOM, Halal certification, and export-related processes (e.g., SKI and SKE).
• Comprehensive understanding of Indonesian regulatory requirements (e.g., BPOM, Halal certification through BPJPH and LPPOM MUI).
• Familiarity with international food safety standards, such as HACCP, ISO 22000:2018, and Codex Alimentarius.
• Knowledge of document control systems and regulatory audit preparation.
• Strong verbal and written communication skills in Bahasa Indonesia and English for liaising with regulatory bodies and internal teams.
• Proficiency in Microsoft Office Suites (Word, Excel, PowerPoint).
• Certification in Halal compliance or participation in Halal competency training.
• Experience working with export regulations and documentation.

Only shortlisted candidates will be contacted.