PHARMA REGISTRATION SUPERVISOR

Location: Jakarta

This is a full-time, on-site position for a Pharma Registration Supervisor based in Jakarta. The successful candidate will be responsible for leading and coordinating pharmaceutical product registration activities to ensure full compliance with BPOM regulations and applicable standards.

The role includes preparation and review of regulatory dossiers, coordination with regulatory authorities, monitoring of registration timelines, and ensuring timely issuance of Marketing Authorization in accordance with defined targets.

Job Responsibility:

• Review, prepare, and manage CTD/ACTD dossiers (Administrative, Quality, Non-Clinical, and Clinical) for BPOM registration and export purposes.
• Execute registration activities for pharmaceutical products, including new drugs, biological products, generic/copy products, imported products, and export-only products, in line with established timelines.
• Manage regulatory correspondence and consultations with BPOM.
• Coordinate effectively with internal teams, manufacturing sites, and relevant stakeholders to ensure smooth registration processes.
• Ensure compliance with the latest BPOM regulations and applicable registration requirements.
• Monitor and control registration timelines to ensure timely issuance of Marketing Authorization (NIE/Approval) in accordance with defined targets.

Qualifications:

• Minimum Bachelor’s Degree in Pharmacy or Pharmacist (Apoteker) from reputable university with a minimum GPA of 3.00/4.00.
• Minimum 2 years of experience in pharmaceutical product registration.
• Able to independently prepare registration dossiers in accordance with the latest ACTD/CTD requirements. Able to read, understand, and prepare technical documentation in English.
• Familiar with BPOM e-Registration system (New-Aero).
• Proficiency in regulatory requirements, compliance standards, and related documentation processes for pharmaceutical products.
• Strong organizational and project management skills to oversee registration timelines and ensure timely submissions.
• Excellent research, analytical, and problem-solving skills.
• Effective communication and relationship-building skills to liaise with regulatory agencies and internal teams.
• Attention to detail and high accuracy in preparing and reviewing documents.
• Creative, adaptable, assertive, able to work effectively in a team environment and under strict deadlines.
• Fluent in English is an advantage.