Regulatory Affairs Admin

Ability to register ijin PBF, PAK, CDOB, CDAKB, NIE with KEMENKES.

Pre-registration activities including prep ration of tehcnical dossiers, artwork, marketing materials, compilation of documents or reports and liasing with other stakeholders in the industry

Registration activities including submissions, corrections and responding to KEMENKES enquiries along with related governmental portals such as e-Katalog/Inaproc, LKPP.

Post registration activities including e-reporting, keeping up to date with regulation changes, participation in related activities in Jakarta or designated areas.

Assist in import activities to ensure imported products conform to regulatory rules and administrative activities such as checking of import documents, specifications etc.

Assist in other reporting or administrative duties as required to support main responsibilities.

Strong enough English to understand regulation or technical text and to write and respond effectively.

Self-motivated, detailed and able to work independtly and to follow datelines.

Must be D3 Farmasi Or S1 Farmasi

Will consider fresh graduate if there is evidence of strong technical background and the ability to understand regulation.

Preferably experienced and or familiar with ISO or with other regulatory regimes FDA, CE etc.

Based in Surabaya & Sidoarjo (Waru), Jawa Timur