Deskripsi Pekerjaan
Join our dynamic team as Regulatory Affairs Specialist at Farmasi Indonesia Nusantara! We're seeking a meticulous professional to navigate Indonesia's evolving pharmaceutical regulatory landscape. Shape compliance strategies, ensure product approvals, and safeguard patient safety while advancing your career in one of Southeast Asia's most vibrant healthcare markets.
Why Join Us?
• Industry-leading compensation with performance bonuses
• Comprehensive medical and wellness benefits
• Continuous professional development through BPOM/FDA training
• Collaborative environment with global pharmaceutical experts
• Opportunity to impact national healthcare standards
Tanggung Jawab
- Manage end-to-end product registration dossiers for BPOM and international agencies (FDA, EMA)
- Monitor and interpret regulatory changes in Indonesian pharmaceutical legislation
- Coordinate with Quality Assurance on GMP/GLP compliance audits
- Prepare submissions for marketing authorization variations and renewals
- Liaise with government bodies on regulatory policy advocacy
- Conduct pharmacovigilance signal detection and adverse event reporting
- Maintain electronic submission portals and regulatory documentation systems
Kualifikasi
- S1/S2 degree in Pharmacy, Pharmacology, or related life sciences
- 3+ years' experience in pharmaceutical regulatory affairs
- BPOM registration certification or equivalent international qualification
- Proficiency in regulatory documentation systems (e.g., RIMES, Argus)
- Advanced Bahasa Indonesia and English documentation skills
- Deep knowledge of ASEAN harmonization guidelines
- Experience with pharmacovigilance systems (e.g., PVMS)
- Strong analytical skills with attention to regulatory detail