Regulatory Affairs – Indonesia

Cisema; Jakarta Pusat; Sur place; IDR 324 266 000 - 468 384 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Attention to detail

Problem solving

Independent worker

English proficiency

Formation

Bachelor’s degree in Health Sciences/Engineering/Science

Licensed Pharmacist (Apoteker)

Certified Halal Supervisor

Outils

BPOM submission systems

Halal certification processes

e-Katalog/LKPP registration

Description du poste

We’re Hiring: Regulatory Affairs – Indonesia

Are you passionate about pharmaceutical regulatory compliance and supporting healthcare innovation in Indonesia? We’re looking for a Junior Regulatory Affairs professional with a primary focus on pharmaceutical Drug Master File (DMF) regulatory support, BPOM product-registration variations and lifecycle management. The role will also support medical device and cosmetic regulatory activities, alongside our existing responsibilities across halal certification, health supplements, quality systems, importation and regulatory operations.

This is a great opportunity to be part of agrowing regional teamwith operations across Southeast Asia, China, Hong Kong, Taiwan and South Korea, supporting international manufacturers to successfully enter the Indonesian market.

Key Responsibilities

Pharmaceuticals – Primary Focus: DMF Filing, Variations and Lifecycle Management

• Support ongoing regulatory management of pharmaceutical Drug Master File (DMF) documentation within Indonesia’s medicinal product registration and BPOM variation framework.
• Review existing DMF documentation and relevant pharmaceutical product registration and variation history, and maintain an accurate regulatory status tracker.
• Assess proposed DMF changes for their potential impact on existing medicinal product registrations and help determine the applicable BPOM variation classification and submission pathway.
• Perform dossier gap analyses, identify missing supporting information and coordinate collection of required documents from clients, manufacturers and relevant parties.
• Review dossier updates supplied in English for administrative completeness and consistency, and coordinate the preparation, localization and compilation of BPOM variation documentation.
• Coordinate with the relevant Indonesian marketing authorization holder (MAH) /local registrant and other authorized stakeholders for variation submissions to BPOM.
• Track BPOM submissions and evaluations; coordinate regulatory correspondence, follow-up and preparation of responses to BPOM questions or requests for additional information.
• Support pharmaceutical dossier records, approved change implementation, post-approval regulatory documentation and ongoing compliance.

Additional Regulatory and Operational Responsibilities – Medical Devices, Cosmetics and Other Products

• Manage and coordinate Halal certification and compliance activities, including preparation of documents, submission coordination, follow-up, and maintenance of Halal-related requirements.
• Perform Halal Supervisor responsibilities in accordance with applicable regulations and the Halal Assurance System (SJPH).
• Provide supporting assistance for product registration and regulatory activities covering Medical Devices, Cosmetics, and Health Supplements.
• Liaise with BPOM, Ministry of Health (MoH), Halal authorities, and other relevant regulatory agencies regarding regulatory submissions and compliance matters.
• Monitor regulatory developments and prepare regulatory reports, regulatory updates, and compliance assessments for internal teams and clients.
• Maintain regulatory databases, product registrations, licenses, and compliance documentation to ensure ongoing regulatory compliance.
• Support importation activities, including coordination of import-related documents and communication with relevant parties.
• Coordinate e-Katalog/LKPP activities, including product listing, document preparation, data maintenance, and operational follow-up.
• Support preparation and management of regulatory inspections and audits, including CDAKB, BPOM, halal, and other quality system audits.
• Collaborate with clients, principals, distributors, and internal stakeholders to ensure timely regulatory approvals and project execution.
• Manage day-to-day operational activities related to regulatory and market access projects, including documentation, coordination, follow-up, scheduling, and administrative tracking.
• Represent the company at exhibitions, industry events, and regulatory meetings while providing regulatory support for business development activities.

Requirements

Pharmaceutical Regulatory Qualifications – Primary Priority

Hands-on experience with Indonesian BPOM pharmaceutical registration and/or post-approval variation submissions is strongly preferred; practical DMF/active pharmaceutical ingredient documentation experience is a significant advantage.

Understanding of pharmaceutical dossier compilation, change assessment, BPOM variation classifications, local MAH/registrant coordination and authority deficiency responses.

Pharmacy or Pharmaceutical Sciences background and Indonesian Registered Pharmacist (Apoteker) qualification are especially desirable for this pharmaceutical-focused role.

• Bachelor’s degree in Health Sciences, Engineering, or Science-related disciplines(Licensed Pharmacist is a strong advantage) - to act as the company’s contact person.
• Certified Halal Supervisor is highly desirable.
• Minimum5 to 7 years experiences in Regulatory Affairs, Product Registration, Quality Assurance, Halal Compliance, Importation or related fields is preferred.
• Knowledge of importation processes, customs documentation, import permits, and regulatory requirements for imported products.
• Fluent inEnglish (written and spoken)for communication with international clients and authorities.
• Excellent attention to detail, problem-solving, and the ability to work independently across multiple projects.

Preferred Qualifications

Pharmaceutical DMF and BPOM variation experience will receive priority in shortlisting. Experience in medical devices and cosmetics remains valuable, and knowledge of health supplements and halal compliance is advantageous.

• Registered Pharmacist (Apoteker) qualification is highly preferred.
• Experience in product registration, renewal, variation, and post-market regulatory compliance.
• Certified Halal Supervisor or experience supporting halal certification processes.
• Familiarity with CDAKB, BPOM inspections, halal audits, or other quality management systems.
• Good understanding of regulatory submission systems such as BPOM, Ministry of Health (MoH), OSS, and related platforms is an advantage.
• Familiarity with Indonesia e-Catalogue (LKPP/e-Katalog) registration, maintenance, and government procurement processes.

Employment Type:Full-Time

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