Deskripsi Pekerjaan
Join Samco Farma as a Registration Section Head and lead the critical process of pharmaceutical product registration. This pivotal role ensures full compliance with BPOM regulations while maintaining meticulous documentation standards. You'll spearhead strategic initiatives to streamline registration workflows, coordinate cross-functional teams, and drive excellence in regulatory affairs. The position offers an opportunity to shape compliance frameworks and contribute directly to patient access to life-saving medications in Indonesia's dynamic pharmaceutical landscape.
Tanggung Jawab
- Oversee end-to-end pharmaceutical product registration processes for new and existing products
- Ensure full compliance with BPOM regulations and documentation requirements
- Lead and mentor registration team members to achieve performance targets
- Develop and implement regulatory strategies for market entry approvals
- Coordinate with R&D, quality, and production teams for seamless dossier preparation
- Monitor regulatory changes and update internal compliance frameworks
- Manage registration timelines and ensure on-time submission to BPOM
Kualifikasi
- Bachelor's degree in Pharmacy, Biology, Chemistry, or related scientific field
- Minimum 5 years of experience in pharmaceutical product registration
- Proven expertise in BPOM regulations and Indonesian pharmaceutical compliance
- Strong leadership experience with team management responsibilities
- Exceptional attention to detail in documentation and dossier preparation
- Advanced knowledge of registration procedures and regulatory requirements
- Excellent communication skills for stakeholder coordination
- Proficiency in regulatory software and documentation systems