PHARMA REGISTRATION SUPERVISOR

International Beauty Products Ltd.; Jakarta Pusat; On-site; IDR 223,200,000 - 357,120,000; Full time

Job summary

International Beauty Products Ltd. in Jakarta is seeking a Pharma Registration Supervisor to lead and coordinate all BPOM registration activities, ensuring compliance with current regulations and timelines.

You will prepare CTD/ACTD dossiers, manage regulatory submissions for new and imported products, and liaise with internal teams and BPOM to secure timely Marketing Authorizations. The role requires a Pharmacy degree, 2+ years in registration, English documentation, and strong project

Qualifications

• Bachelor's degree in Pharmacy or Pharmacist with GPA ≥ 3.0.
• At least 2 years of experience in pharmaceutical product registration.
• Ability to independently prepare CTD/ACTD dossiers.
• Proficient in English for technical documentation.
• Familiar with BPOM e-Registration system (New-Aero).
• Strong organizational and project management skills to oversee timelines.
• Excellent research, analytical, and problem-solving abilities.
• Good communication with regulatory agencies and internal teams.

Responsibilities

• Review and manage CTD/ACTD dossiers for BPOM registration and export.
• Execute registration activities for various products in line with timelines.
• Manage regulatory correspondence with BPOM.
• Coordinate with internal teams and manufacturing sites to ensure smooth processes.
• Ensure compliance with BPOM regulations and registration requirements.
• Monitor registration timelines and obtain NIE/Approval within targets.

Skills

Regulatory coordination

Project management

Documentation

English communication

Regulatory compliance

Education

Bachelor's Degree in Pharmacy (GPA 3.00/4.00)

Tools

BPOM e-Registration (New-Aero)

Job description

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.

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.