Lowongan Kerja Jawa Barat Posisi Regulatory Affairs Specialist di Pt. Yili indonesia dairy

Info Loker

Perusahaan	Pt. Yili indonesia dairy
Posisi	Regulatory Affairs Specialist
Tempat	Jawa Barat
Tingkatan Kerja	Supervisor/Koordinator
Kualifikasi	Diploma Pascasarjana, Gelar Professional, Magister (S2), Sarjana (S1)
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Farmasi, Layanan Kesehatan
Gaji Min	Rp. 1.800.000
Gaji Max	Rp. 5.500.000

Job Description :

1. Regulatory Strategy: Develop and execute regulatory strategies to gain approval for new products or maintain existing product approvals. Collaborate with cross-functional teams to ensure alignment with business objectives.
2. Regulatory Submissions: Prepare, compile, and submit regulatory documents, such as product registrations, submissions to regulatory agencies, and periodic reports, that is : BPOM Product Registration (MD, ML, P5, ect), Halal Product Registration, Lead, collect, update and assess Indonesia Food Regulation & SEA Overseas Country Food Regulation
3. Compliance Monitoring: Continuously monitor and interpret regulatory changes, guidelines, and standards. Ensure that the company is in compliance with all relevant regulations and standards.
4. Quality Assurance: Collaborate with the Quality Assurance department to maintain high product quality and ensure that quality management systems are compliant with regulatory requirements.
5. Product Labeling and Documentation: Review and approve product labeling and documentation to ensure accuracy and compliance with regulations.
6. Product Development Support: Provide regulatory guidance to R&D and product development teams to ensure that new products are developed in accordance with regulatory requirements.
7. Risk Assessment: Conduct risk assessments and impact analyses of regulatory changes, ensuring that the company is well-prepared for any potential challenges.
8. Communication: Establish and maintain communication with regulatory authorities, responding to inquiries, inspections, and audits. Represent the company’s regulatory interests as needed.
9. Collaboration: Collaborate with cross-functional teams, including legal, marketing, and production, to ensure that all departments are aligned with regulatory requirements.
10. Documentation and Records: Maintain organized and up-to-date regulatory documentation, records, and archives as required by regulations.

Qualification

1. Bachelor’s degree in a related field (e.g., regulatory affairs, biology, chemistry, pharmacy, or a related discipline). Advanced degrees or certifications (e.g., RAC) may be preferred.
2. 3 (three) years of experience in regulatory affairs (number of years may vary depending on the level of the position).
3. Strong knowledge of relevant regulations and guidelines (e.g., FDA, EMA, FSSC 22000, etc.).
4. Excellent communication and interpersonal skills.
5. Detail-oriented with strong analytical and problem-solving abilities.
6. Proficiency in regulatory BPOM, BPJPH software and tools.
7. Ability to work independently and as part of a team.
8. Placement work at GIIC Deltamas Cikarang Kabupaten Bekasi

Lamar kerja

Deskripsi Perusahaan

Info Perusahaan

• Industri: Lainnya
• Ukuran Perusahaan: 201 - 500 pekerja
• Waktu Proses Lamaran: 29 hari
• Lokasi: GIIC - Cikarang