Pharmacist (Manufacturing & BPOM Regulatory)

Hirea Group Bhuana; Jakarta Utara; On-site; IDR 200,880,000 - 334,800,000; Full time

Job summary

Hirea Group Bhuana is seeking a qualified Pharmacist to join the manufacturing team and lead BPOM licensing and product registration activities. The role requires coordinating with BPOM, preparing regulatory submissions, and ensuring compliance with Indonesian regulations and GMP standards.

The ideal candidate has 2–3 years of relevant experience, strong documentation skills, and proficiency in MS Office. Collaboration with QA, QC, Production, and R&D is essential to maintain regulatory

Qualifications

• Bachelor's Degree in Pharmacy (S1 Farmasi) from a recognized university.
• Pharmacist Professional Degree (Apt.) is preferred/required.
• Minimum 2–3 years of experience in pharmaceutical, cosmetic, food supplement, or related manufacturing industries.
• Proven experience in BPOM licensing, product registration, and regulatory affairs.
• Good understanding of BPOM regulations and product registration procedures in Indonesia.
• Experience handling regulatory documents and communicating with regulatory authorities.
• Strong attention to detail, analytical skills, and documentation skills.
• Good communication and coordination skills.
• Able to work independently as well as collaboratively with cross-functional teams.
• Proficient in Microsoft Office, particularly Word and Excel.

Responsibilities

• Handle and coordinate BPOM licensing and product registration processes for company products.
• Prepare, review, and submit regulatory documents required for BPOM registration and licensing.
• Monitor and follow up on BPOM submissions, evaluations, approvals, and regulatory requirements.
• Ensure product documentation complies with applicable BPOM regulations and Indonesian pharmaceutical regulations.
• Coordinate with BPOM and relevant regulatory authorities when required.
• Work closely with Quality Assurance, Quality Control, Production, R&D, and other departments to ensure regulatory compliance.
• Review product information, labels, packaging, specifications, and supporting documents for regulatory compliance.
• Maintain and update regulatory documentation and product registration records.
• Monitor changes in BPOM regulations and assess their impact on company products and processes.
• Support product renewal,variation, amendment, and other regulatory submissions.
• Ensure all regulatory activities are properly documented and completed within the required timeline.
• Provide regulatory advice and support to internal teams regarding BPOM requirements.

Skills

Regulatory affairs

BPOM licensing

Documentation

Regulatory submissions

Communication

Attention to detail

MS Office

Education

Bachelor's Degree in Pharmacy (S1 Farmasi)

Pharmacist Professional Degree (Apt.)

Tools

Microsoft Office (Word, Excel)

Job description

Industry: Manufacturing

Employment Type: Full-time

Job Description

We are looking for a qualified and experienced Pharmacist to join our manufacturing team. The successful candidate will be responsible for supporting pharmaceutical regulatory activities, particularly BPOM licensing and product registration, while ensuring compliance with applicable Indonesian regulations and company quality standards.

Key Responsibilities

Handle and coordinate BPOM licensing and product registration processes for company products.

Prepare, review, and submit regulatory documents required for BPOM registration and licensing.

Monitor and follow up on BPOM submissions, evaluations, approvals, and regulatory requirements.

Ensure product documentation complies with applicable BPOM regulations and Indonesian pharmaceutical regulations.

Coordinate with BPOM and relevant regulatory authorities when required.

Work closely with Quality Assurance, Quality Control, Production, R&D, and other departments to ensure regulatory compliance.

Review product information, labels, packaging, specifications, and supporting documents for regulatory compliance.

Maintain and update regulatory documentation and product registration records.

Monitor changes in BPOM regulations and assess their impact on company products and processes.

Support product renewal,variation, amendment, and other regulatory submissions.

Ensure all regulatory activities are properly documented and completed within the required timeline.

Provide regulatory advice and support to internal teams regarding BPOM requirements.

Requirements

Bachelor's Degree in Pharmacy (S1 Farmasi) from a recognized university.

Pharmacist Professional Degree (Apt.) is preferred/required.

Minimum 2–3 years of experience in pharmaceutical, cosmetic, food supplement, or related manufacturing industries.

Proven experience in BPOM licensing, product registration, and regulatory affairs.

Good understanding of BPOM regulations and product registration procedures in Indonesia.

Experience handling regulatory documents and communicating with regulatory authorities.

Strong attention to detail, analytical skills, and documentation skills.

Good communication and coordination skills.

Able to work independently as well as collaboratively with cross-functional teams.

Proficient in Microsoft Office, particularly Word and Excel.

Preferred Qualifications

Experience handling BPOM e-Registration / regulatory submission systems.

Experience with product registration, renewal, variation, and post-market regulatory activities.

Experience in a manufacturing environment.

Knowledge of Good Manufacturing Practices (GMP/CPOTB/CPOB) and relevant quality standards.

Having a valid SIPA and/or experience as a responsible pharmacist (Apoteker Penanggung Jawab) will be an advantage.