Regulatory Affairs Specialist (Indonesia): DMF & BPOM Focus

Cisema; Jakarta Pusat; On-site; IDR 324,266,000 - 468,384,000; Full time

Job summary

Cisema is hiring a Junior Regulatory Affairs professional to support DMF regulatory activities, BPOM variation submissions, and lifecycle management in Indonesia. You will contribute to medical devices, cosmetics, halal compliance, and health supplements as part of a regional team serving Southeast Asia and other markets.

Qualifications include a health sciences/pharmacy background, Indonesian pharmacist registration preferred, and fluent English.

Qualifications

• Hands-on experience with Indonesian BPOM pharmaceutical registrations and post-approval variation submissions preferred.
• Understanding of dossier compilation, change assessment and BPOM variation classifications.
• Indonesian Pharmacist qualification desirable for this role.

Responsibilities

• Support DMF filings, BPOM variations, and lifecycle management.
• Coordinate with MAH/registrant and stakeholders for submissions.
• Track BPOM submissions and prepare responses to questions or requests for information.
• Assist regulatory record-keeping and post-approval documentation.

Skills

Attention to detail

Problem solving

Independent worker

English proficiency

Education

Bachelor’s degree in Health Sciences/Engineering/Science

Licensed Pharmacist (Apoteker)

Certified Halal Supervisor

Tools

BPOM submission systems

Halal certification processes

e-Katalog/LKPP registration

Job description

Cisema is hiring a Junior Regulatory Affairs professional to support DMF regulatory activities, BPOM variation submissions, and lifecycle management in Indonesia. You will contribute to medical devices, cosmetics, halal compliance, and health supplements as part of a regional team serving Southeast Asia and other markets.

Qualifications include a health sciences/pharmacy background, Indonesian pharmacist registration preferred, and fluent English.