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A leading food and beverage company based in Cibitung is looking for a Regulatory Affairs Specialist. In this role, you will manage the product registration process, ensuring compliance with local regulations while building strong relationships with stakeholders. The ideal candidate has a minimum of 3 years of experience in regulatory affairs, particularly with processed food and health supplements, along with excellent communication skills and an ability to work collaboratively across teams.
Execute and monitor the product registration process.
Coordinate with related departments and principals to request registration documents, review documents, prepare a complete registration dossier, submit to BPOM system, including additional data fulfillment, monitor & follow up until approval is obtained (including negotiation with BPOM if necessary).
Ensure all regulatory activities (new product, variation, and renewal submissions) comply with current regulations, requirements, and practices.
Ensure approvals are obtained within the committed timeline.
Ensure Compliance audits are conducted according to schedule until final reporting.
Ensure timely follow-up on findings from external audits/Inspections (BPOM, BPJPH, Certification Body).
Ensure timely follow-up on findings from internal Compliance audits.
Liaise with Manager Department to obtain advice on regulatory strategy and approach.
Build and maintain good relationships with internal and external stakeholders.