Deskripsi pekerjaan
Emerhub Consulting Indonesia membuka kesempatan bagi profesional yang berdedikasi untuk bergabung sebagai Senior Regulatory Affair dengan latar belakang profesi apoteker. Peran ini berfokus pada pengembangan strategi regulasi untuk penetapan pasar, perizinan, dan registrasi produk, serta memastikan seluruh proses kepatuhan hukum dan regulasi terpenuhi dengan baik bagi para klien perusahaan. Tanggung jawab utama posisi ini mencakup penyusunan strategi regulasi, pelaksanaan analisis kesenjangan regulasi dan penilaian kepatuhan, serta penyusunan jadwal regulasi dan rencana proyek. Selain itu, Anda akan mengelola proses pengajuan regulasi dari awal hingga akhir untuk produk kosmetik, alat kesehatan, dan pendaftaran produk makanan, yang meliputi peninjauan dokumen teknis, penyiapan dokumen pengajuan, dan koordinasi legalisasi dokumen. Posisi ini juga bertindak sebagai penghubung utama dengan instansi pemerintah terkait, mengelola banyak proyek klien secara bersamaan, memantau regulasi baru dan pembaruan kebijakan, serta memastikan seluruh pengajuan mematuhi peraturan yang berlaku dan tenggat waktu yang disepakati. Kandidat juga diharapkan mampu mengembangkan dan meningkatkan Standar Operasional Prosedur (SOP), menjaga ketepatan waktu penyelesaian proyek setidaknya 95%, memantau batas waktu proyek secara proaktif, mengidentifikasi potensi risiko regulasi sejak dini, serta mempertahankan kompetensi profesional dengan berpartisipasi dalam pelatihan dan seminar regulasi.
Tanggung jawab: Develop regulatory strategies for market entry, licensing, and product registration; Conduct regulatory gap analysis and compliance assessments; Prepare regulatory timelines and project plans; Manage end-to-end regulatory submissions for Cosmetic Product; Medical Devices; Food Product Registration; inclusive to Reviewing technical documents, Preparing submission dossiers, Coordinating document legalization when required; Act as the primary liaison with relevant government agencies; Manage multiple client projects simultaneously; Monitor new regulations and policy updates; Ensure all submissions comply with applicable regulations; Develop and improve Standard Operating Procedures (SOPs); KPI; Achieve at least 95% on-time completion of all assigned regulatory projects; Ensure all regulatory submissions are submitted before the agreed client deadline; Monitor project timelines and proactively escalate potential delays; Ensure all submission dossiers are complete, accurate, and compliant before submission; Monitor new and updated regulations relevant to client industries; Effectively manage multiple regulatory projects simultaneously; Identify potential regulatory risks at an early stage; Maintain professional competency by participating in regulatory training and seminars; Any specific skills, experience, or education requirement.
Kualifikasi: Bachelor's Degree (S1) in Pharmacy; Willingness for its Indonesian pharmacist license (STRA) to be used as PJT (Company Representative for BPOM; Additional certifications in Regulatory Affairs, Quality Management, or Project Management are an advantage; Minimum 3 years of experience in Regulatory Affairs, preferably within a regulatory consulting firm, pharmaceutical company, cosmetic company, medical device company, or healthcare industry; Experience managing multiple regulatory projects simultaneously; Experience communicating and coordinating directly with government authorities; Kindly Apply here for better screening: https://draft.jobs/careers/emerhub-consulting-indonesia/senior-regulatory-affair-apoteker.
Tanggung jawab
- Develop regulatory strategies for market entry, licensing, and product registration
- Conduct regulatory gap analysis and compliance assessments
- Prepare regulatory timelines and project plans
- Manage end-to-end regulatory submissions for Cosmetic Product; Medical Devices; Food Product Registration; inclusive to Reviewing technical documents, Preparing submission dossiers, Coordinating document legalization when required
- Act as the primary liaison with relevant government agencies
- Manage multiple client projects simultaneously
- Monitor new regulations and policy updates
- Ensure all submissions comply with applicable regulations
- Develop and improve Standard Operating Procedures (SOPs)
- KPI
- Achieve at least 95% on-time completion of all assigned regulatory projects
- Ensure all regulatory submissions are submitted before the agreed client deadline
- Monitor project timelines and proactively escalate potential delays
- Ensure all submission dossiers are complete, accurate, and compliant before submission
- Monitor new and updated regulations relevant to client industries
- Effectively manage multiple regulatory projects simultaneously
- Identify potential regulatory risks at an early stage
- Maintain professional competency by participating in regulatory training and seminars
- Any specific skills, experience, or education requirement
Kualifikasi
- Bachelor's Degree (S1) in Pharmacy
- Willingness for its Indonesian pharmacist license (STRA) to be used as PJT (Company Representative for BPOM
- Additional certifications in Regulatory Affairs, Quality Management, or Project Management are an advantage
- Minimum 3 years of experience in Regulatory Affairs, preferably within a regulatory consulting firm, pharmaceutical company, cosmetic company, medical device company, or healthcare industry
- Experience managing multiple regulatory projects simultaneously
- Experience communicating and coordinating directly with government authorities
- Kindly Apply here for better screening: https://draft.jobs/careers/emerhub-consulting-indonesia/senior-regulatory-affair-apoteker
Informasi lowongan
- Tipe pekerjaan
- Full-time
- Pendidikan
- S1
- Gaji
- Negosiasi