Regulatory Affairs

2 weeks ago

Tangerang, Banten, Indonesia Apotek Super Full time

Key Responsibilities1. BPOM Registration & Submission

  • Prepare, compile, and submit product dossiers for BPOM (e-BPOM, ASROT, New-AERO), including technical documents, certificates, test reports, and administrative files.
  • Upload and manage all documents in the BPOM digital platforms.
  • Monitor application progress and respond promptly to BPOM evaluations, queries, and correction requests.

2. Manufacturer & Documentation Coordination

  • Liaise with Chinese manufacturers to obtain required documents such as GMP certificates, Certificate of Free Sale (CFS), Certificate of Analysis (CoA), specifications, raw material data, stability studies, and testing reports.
  • Ensure all foreign documents are complete, valid, translated, and legalized when required.
  • Review technical documentation for accuracy and compliance with Indonesian regulatory standards.

3. Regulatory Compliance & Label Control

  • Ensure that product formulas, claims, and packaging artwork fully comply with BPOM guidelines and Indonesian labeling regulations.
  • Review and approve marketing materials, ensuring claims remain scientifically valid and legally acceptable.
  • Conduct regulatory assessments for new ingredients, formulations, or product innovations.

4. Inspection & Regulatory Interactions

  • Manage BPOM inspections, audits, or remote evaluations related to imported products or foreign manufacturer GMP compliance.
  • Coordinate follow-up actions, corrective responses, and documentation for any BPOM findings.
  • Maintain strong professional relationships with regulatory authorities.

5. Post-Market Compliance

  • Monitor regulatory changes and ensure company products remain compliant with updated BPOM regulations.
  • Assist in post-market surveillance activities, including reporting of product quality issues or adverse events.
  • Maintain organized regulatory archives and records for all registered products.

Qualifications
Education & Experience

  • Bachelor's degree in Pharmacy (S.Farm, Apt preferred), Food Science, Chemistry, Biotechnology, or related fields.
  • Minimum 1–3 years of experience in Regulatory Affairs, specifically handling BPOM submissions.
  • Proven experience using e-BPOM, ASROT, and/or New-AERO platforms.
  • Familiarity with GMP, quality documentation, and international product registration requirements.

Technical Skills

  • Strong understanding of BPOM regulations for supplements, cosmetics, medical products, or OTC preparations.
  • Ability to review technical documents and scientific data.
  • Knowledge of product labeling regulations and claim limitations.

Soft Skills

  • Excellent communication skills in Bahasa Indonesia and English (Mandarin is a plus).
  • Strong attention to detail and analytical thinking.
  • Proactive and able to manage deadlines in a fast-paced environment.
  • Comfortable coordinating with cross-functional teams (QA, warehouse, logistics, marketing).

Work Arrangement

  • Position:
    Full-time
  • Reports to:
    Head of Regulatory Affairs / Operations Manager
  • Location:
    BSD, Tangerang Selatan (hybrid/flexible depending on company structure)

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