Regulatory Affairs Associate — Pharma Registrations & Dossiers

PT. Elit Solusi Niaga; Jakarta Pusat; On-site; IDR 44,640,000 - 78,120,000; Full time

Job summary

PT. Elit Solusi Niaga is seeking a Regulatory Affairs Assistant to support the preparation and submission of product registration documents to government authorities in Indonesia.

You will verify document accuracy, coordinate client materials, and respond to regulator requests while keeping teams updated on changes. The role requires a pharmacy-related degree, up to 1 year of experience, and strong English communication.

Qualifications

• Bachelor's Degree in Pharmacy or Pharmacist qualification.
• Fresh Graduate or up to 1 year of Regulatory Affairs experience.
• Internship in Regulatory Affairs, especially with consulting firms, preferred.
• Strong attention to detail and accuracy.
• Good written and verbal English communication.
• Proficient in Microsoft Office.
• Able to work independently, manage multiple tasks, and meet deadlines.
• Proactive, responsible, and eager to learn.

Responsibilities

• Assist in preparing product registration documents for submission to government (BPOM or Kemenkes).
• Verify completeness and accuracy of regulatory documentation.
• Assist in preparing dossiers according to government requirements.
• Coordinate document collection from clients.
• Assist in responding to requests for additional documents from regulatory authorities.
• Summarize regulatory changes for internal discussions.
• Prepare progress reports for ongoing projects.
• Ensure submitted documents comply with applicable regulations.
• Support the preparation of Standard Operating Procedures (SOPs).

Skills

Attention to detail

English communication

Microsoft Office

Independent working

Regulatory knowledge

Education

Bachelor's Degree in Pharmacy

Pharmacist

Job description

PT. Elit Solusi Niaga is seeking a Regulatory Affairs Assistant to support the preparation and submission of product registration documents to government authorities in Indonesia.

You will verify document accuracy, coordinate client materials, and respond to regulator requests while keeping teams updated on changes. The role requires a pharmacy-related degree, up to 1 year of experience, and strong English communication.