Scientific and Regulatory Affairs Specialist

PT Arkray · 📍 Jakarta Selatan, Jakarta Raya · Diposting 2026-10-13
FULL_TIME⭐ TERVERIFIKASI
Rp 5.700.000 - Rp 8.550.000 per month
PT Arkray is seeking a highly motivated Scientific and Regulatory Affairs Specialist to join our team. In this role, you will be responsible for ensuring that our products comply with all relevant regulations and standards. You will work closely with our regulatory affairs team to develop and implement strategies to ensure compliance and to manage any regulatory issues that may arise. This is a great opportunity for a professional with a strong background in scientific and regulatory affairs to join a dynamic and growing company.

📋 Tanggung Jawab Pekerjaan

Develop and implement strategies to ensure compliance with all relevant regulations and standards,Monitor regulatory developments and ensure that our products and processes are up-to-date with the latest regulations,Manage any regulatory issues that may arise, including investigations, audits, and inspections,Work closely with our regulatory affairs team to ensure that all regulatory requirements are met,Develop and maintain regulatory documentation, including submissions, reports, and correspondence,Provide regulatory training and support to other members of the team as needed,Collaborate with other departments to ensure that our products and processes are compliant with all relevant regulations,Stay up-to-date with the latest regulatory developments and trends in the industry

🎓 Kualifikasi & Syarat

Bachelor's degree in a relevant field, such as pharmacy, chemistry, or regulatory affairs,Minimum of 3 years of experience in scientific and regulatory affairs, preferably in the pharmaceutical or healthcare industry,Strong knowledge of relevant regulations and standards, such as GMP, GLP, and GDP,Excellent written and verbal communication skills,Strong analytical and problem-solving skills,Ability to work well under pressure and meet tight deadlines,Familiarity with regulatory software and systems, such as Regulatory Affairs Management Systems (RAMS),Fluency in English is a plus

🛠️ Keahlian

Regulatory affairsRegulatory complianceRegulatory strategyRegulatory documentationRegulatory trainingRegulatory softwarePharmaceutical regulationsHealthcare regulations
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