Regulatory Affairs Admin

PT Gidion Jaya; Sidoarjo; Presencial; IDR 89.280.000 - 156.240.000; Jornada completa

Descripción de la vacante

PT Gidion Jaya invites applications for a Regulatory Affairs role focused on Indonesian KEMENKES registrations and compliance. You will handle pre-registration dossiers, submissions, and post-registration reporting, ensuring alignment with regulatory changes.

Based in Surabaya/Sidoarjo, candidates with pharma degrees and regulatory knowledge are preferred. English proficiency is required; fresh graduates with strong regulatory background are welcome.

Formación

• Fluent in English to understand regulations and write responses.
• Detail-oriented and able to meet deadlines.
• D3 Pharmacy or S1 Pharmacy degree.
• Fresh graduates welcome with strong regulatory background.
• Familiar with ISO or FDA/CE regulatory regimes.

Responsabilidades

• Register ijin PBF, PAK, CDOB, CDAKB, NIE with KEMENKES.
• Prepare technical dossiers, artwork, and marketing materials.
• Manage submissions, corrections, and responses to KEMENKES.
• Assist import activities to ensure regulatory conformity.
• Liaise with stakeholders and support reporting duties.

Conocimientos

English proficiency

Regulatory documentation

Deadline-oriented

Independent worker

Educación

D3 Farmasi / S1 Farmasi

Herramientas

ISO familiarity

Descripción del empleo

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

Pre-registration activities including prepration 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.

REQUIREMENTS

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