Regulatory Affairs

PT. WISELIE INTERNATIONAL SOLUTIONS; Tangerang; On-site; IDR 180,000,000 - 240,000,000; Full time

Job summary

PT. WISELIE INTERNATIONAL SOLUTIONS seeks a Regulatory Affairs Specialist to manage end-to-end product registration for cosmetics and PKRT, ensure regulatory compliance, and oversee advertising and packaging compliance.

You will coordinate with government agencies and internal teams to maintain licenses and permits. The role requires 1+ year in regulatory affairs, pharmacy education, and proficiency with e-Regalkes/Kereg and Notifkos.

Qualifications

• Graduate of Professional Pharmacy Education (preferably with active STRA).
• Minimum 1 year of work experience in Regulatory Affairs, preferably FMCG/Cosmetics/PKRT.
• Proficient with e-Regalkes/Kereg and Notifkos registration systems.
• Understanding OSS portal-based licensing procedures.
• Understanding CPOB, CPKB, CPPKRTB guidelines.
• High administrative capability; meticulous attention to numbers and documentation.
• Ability to communicate professionally with government officials and internal stakeholders.
• Able to handle multiple registration projects with strict deadlines.

Responsibilities

• Compile, organize, and review documents for new product registration, variations, and renewal of PKRT and Cosmetic products.
• Perform accurate product registration through official government portals (e-Regalkes/Kereg for PKRT/Alkes and Notifkos for Cosmetics).
• Monitor registration status and ensure SLA compliance at each stage.
• Respond promptly to Additional Data Requests or rejections from Kemenkes/BPOM evaluators.
• Prepare facility compliance documents and accompany auditors during inspections by BPOM, Kemenkes, or Health Services.
• Collaborate with Production and QA/QC to implement CPKB/CPPKRTB.
• Submit CAPA reports post-inspection until approval or compliance certificate is obtained.
• Cross-review packaging design drafts, labeling, brochures, and digital marketing materials.
• Ensure packaging claims and logos comply with BPOM/Kemenkes advertising guidelines.
• Manage company legal documents through OSS (NIB, certificates, environmental permits).

Skills

Regulatory compliance

Documentation management

Regulatory liaison

Education

Professional Pharmacy Education

Active Pharmacist Registration (STRA)

Tools

e-Regalkes/Kereg

Notifkos

OSS portal

Job description

The Regulatory Affairs Specialist is responsible for end-to-end management of the entire product registration cycle, regulatory compliance, and legality of the company's production facilities. This position ensures all products (Cosmetics & PKRT) are legal for distribution, packaging and promotional materials comply with advertising regulations, and production facilities consistently meet CPKB and CPPKRTB standards. This role serves as the company's strategic bridge for communication and negotiation with relevant government agencies (Kemenkes, BPOM, BPJPH, etc.).

Key responsibilities

Compile, organize, and review technical and administrative documents for new product registration, variations, and renewal of PKRT and Cosmetic products

Perform accurate product registration through official government electronic portals (e-Regalkes/Kereg for PKRT/Alkes and Notifkos for Cosmetics)

Monitor registration application status regularly and ensure each stage complies with government Service Level Agreements (SLA)

Respond to Additional Data Request Letters (SPTD) or rejections from Kemenkes/BPOM evaluators promptly, comprehensively, and on time

Prepare facility compliance documents, act as company representative (PIC), and accompany auditors during facility inspections by BPOM, Kemenkes, or Health Services

Collaborate with Production and QA/QC teams to ensure implementation of Good Cosmetic Manufacturing Practices (CPKB) and Good PKRT Manufacturing Practices (CPPKRTB)

Prepare and submit Corrective and Preventive Action (CAPA) reports post-inspection to relevant agencies until approval or compliance certificate is obtained

Conduct cross-review of packaging design drafts, labeling, brochures, and digital marketing materials

Ensure all product claims, logos, and text layout on packaging comply with BPOM/Kemenkes advertising guidelines to prevent warnings or product recalls

Manage, monitor, and update company legal documents through OSS system, including NIB, Standard Certificates, and Environmental Permits

Qualifications

Graduate of Professional Pharmacy Education (preferably with active STRA - Pharmacist Registration Certificate)

Minimum 1 year of actual work experience in Regulatory Affairs, preferably from Fast-Moving Consumer Goods (FMCG), Cosmetics, or Medical Devices/PKRT industries

Proficient and proven ability to operate e-Regalkes/Kereg (Kemenkes) and Notifkos (BPOM) registration systems

Understanding of basic business licensing registration procedures based on risk through the OSS portal

Understanding of CPOB, CPKB, and CPPKRTB guidelines

High administrative capability; meticulous attention to numbers, formulas, claim language, and completeness of legal documents

Able to communicate professionally, diplomatically, and persuasively when dealing with government officials and internal company stakeholders

Able to work under pressure, demonstrates high initiative, and accustomed to managing multiple registration projects simultaneously with strict deadlines