job description
Join Asia Bandar Alam as a Regulatory Affairs Specialist and play a pivotal role in ensuring compliance for cosmetic and PKRT (Traditional Medicine, Health Supplements, and Cosmetics) products in Indonesia’s dynamic regulatory landscape. This position is ideal for detail-oriented professionals passionate about navigating complex regulatory frameworks while supporting product licensing, documentation, and reporting.
Based in the vibrant heart of Bali (Denpasar/Badung), you will collaborate with cross-functional teams to streamline registration processes, mitigate compliance risks, and maintain up-to-date knowledge of local and international regulations. Your expertise will directly contribute to the company’s ability to bring high-quality products to market efficiently and legally.
This is a full-time opportunity for individuals with a background in pharmaceuticals, cosmetics, or regulatory affairs who thrive in a fast-paced, detail-driven environment. If you’re ready to make an impact in a growing industry, we’d love to hear from you.
Responsibility
- Manage end-to-end product registration processes for cosmetics and PKRT items in compliance with Indonesian BPOM (National Agency of Drug and Food Control) regulations.
- Prepare, review, and submit regulatory documentation, including dossiers, labels, and technical files, ensuring accuracy and completeness.
- Monitor and interpret updates to local and international regulatory requirements, advising internal teams on necessary adjustments.
- Coordinate with manufacturing, R&D, and legal teams to gather required data for submissions and address compliance gaps.
- Maintain a tracking system for registration timelines, renewals, and post-market surveillance obligations.
- Liaise with BPOM and other regulatory authorities to clarify requirements, respond to queries, and resolve registration issues.
- Develop and implement SOPs (Standard Operating Procedures) for regulatory processes to improve efficiency and consistency.
- Support audits and inspections by preparing documentation and facilitating communication with regulators.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field; a master’s degree is a plus.
- Minimum 3 years of experience in regulatory affairs, product registration, or compliance within the cosmetic, pharmaceutical, or PKRT industry.
- In-depth knowledge of Indonesian BPOM regulations and familiarity with ASEAN cosmetic directives.
- Proven track record of successful product registrations and submissions to regulatory bodies.
- Excellent written and verbal communication skills in English and Bahasa Indonesia.
- Strong analytical and organizational skills, with the ability to manage multiple priorities under tight deadlines.
- Proficiency in Microsoft Office (Excel, Word) and regulatory management software.
- Detail-oriented with a proactive approach to problem-solving and risk mitigation.