Introduction
We are seeking a diligent Petugas Regulatory Affairs – Pengelolaan Kepatuhan to join our fast‑growing cosmetics and pharmaceutical division in Indonesia. In this pivotal role, you will act as the bridge between our internal teams and regulatory authorities, ensuring that every product we launch complies with the latest BPOM, Ministry of Health, and BPJPH standards. The ideal candidate thrives in a detail‑oriented environment, possesses strong analytical abilities, and enjoys collaborating across research, marketing, and supply‑chain functions.
Responsibilities
- Review, prepare, input, and continuously monitor cosmetic product notifications in accordance with BPOM regulations.
- Manage PKRT (Product Kesehatan Tradisional) notifications, ensuring alignment with Ministry of Health guidelines.
- Oversee halal product registration processes, maintaining compliance with BPJPH requirements.
- Draft, update, and archive the Dokumen Informasi Produk (DIP) to reflect current formulation, labeling, and safety data.
- Stay current with evolving national and regional regulatory frameworks, providing proactive guidance to product development teams.
- Collaborate closely with R&D, Marketing, and Purchasing to integrate regulatory considerations early in the product lifecycle.
- Serve as the primary liaison between external regulators and internal stakeholders, facilitating inspections, audits, and inquiries.
- Maintain a comprehensive regulatory database, ensuring all documentation is accurate, searchable, and audit‑ready.
- Conduct internal compliance training sessions to raise awareness of regulatory obligations among cross‑functional teams.
- Assist in the preparation of risk assessments and product safety dossiers for new launches and post‑market surveillance.
Requirements
- Minimum education: D3/D4 or S1 in Pharmacy, Chemistry, Biology, or a related scientific field.
- At least 1 year of hands‑on experience in Regulatory Affairs within the cosmetics or pharmaceutical industry.
- In‑depth knowledge of Indonesian cosmetic regulations (BPOM), PKRT guidelines, and halal certification processes (BPJPH).
- Strong analytical skills with the ability to interpret complex legal documents and translate them into actionable internal procedures.
- Exceptional attention to detail; capable of handling large volumes of legal and technical documentation without error.
- Excellent written and verbal communication skills in Bahasa Indonesia; proficiency in English is a plus.
- Proven ability to work collaboratively across multidisciplinary teams and manage multiple priorities under tight deadlines.
- Proficiency with regulatory databases, Microsoft Office Suite, and document management systems.
- Gender: Open to all candidates.
- Age: No upper limit; we value experience and competence above age.
Benefits
- Competitive monthly salary commensurate with experience and qualifications.
- Health insurance covering medical, dental, and vision expenses for employees and their immediate families.
- Annual performance bonus tied to individual and company achievements.
- Professional development allowance for certifications, workshops, and industry conferences.
- Paid leave: 12 days of annual leave, plus national holidays and sick leave.
- Flexible working hours with a standard schedule of Monday‑Friday, 08:00‑17:00.
- Company‑provided transportation or reimbursement for commuting costs.
- Opportunities for career advancement within a rapidly expanding organization.
About Company
Our company is a leading player in Indonesia’s beauty and health sector, known for delivering high‑quality, innovative cosmetic and pharmaceutical products that meet rigorous safety standards. With a strong commitment to ethical manufacturing, halal compliance, and sustainable sourcing, we serve a diverse consumer base across the archipelago and export to neighboring markets. Our multidisciplinary teams work in state‑of‑the‑art laboratories and modern production facilities, fostering a culture of continuous improvement, scientific excellence, and regulatory integrity.
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