Entry-Level Regulatory Affairs Assistant - Join a Global Manufacturing Leader in Bali

Are you a detail-oriented professional eager to launch your career in Regulatory Affairs? Kopiko, a leading name in manufacturing and logistics, is seeking a motivated Entry-Level Regulatory Affairs Assistant to join our dynamic team in Badung, Bali. As a key player in the global manufacturing sector, Kopiko is committed to delivering high-quality products while adhering to stringent regulatory standards. This role offers a unique opportunity to work in a vibrant international environment and grow your expertise in regulatory compliance.

In this role, you will work closely with the Regulatory Affairs team to ensure that Kopiko's products meet all local and international regulatory requirements. You will be responsible for gathering and analyzing regulatory information, preparing and submitting regulatory documents, and collaborating with cross-functional teams to ensure compliance. This position is ideal for someone looking to build a career in regulatory affairs, with opportunities for professional development and growth within a supportive and innovative company.

📋 Tanggung Jawab Pekerjaan

• Assist in the preparation and submission of regulatory documents, including dossiers, labels, and other required materials.
• Conduct research and analysis of regulatory requirements and guidelines.
• Collaborate with cross-functional teams to ensure compliance with regulatory standards.
• Monitor regulatory changes and updates, and provide recommendations for necessary actions.
• Assist in the development and implementation of regulatory strategies and plans.
• Support the Regulatory Affairs team in maintaining and updating regulatory databases and records.
• Participate in regulatory inspections and audits, and provide necessary documentation and support.
• Maintain accurate and up-to-date records of regulatory activities and communications.

🎓 Kualifikasi & Syarat

• Bachelor's degree in Pharmacy, Life Sciences, or a related field.
• Minimum of 1-2 years of experience in regulatory affairs or a related field.
• Familiarity with regulatory requirements and guidelines for pharmaceuticals or related products.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Proficiency in English, both written and spoken.
• Ability to work in a fast-paced, dynamic environment.
• Attention to detail and a commitment to accuracy and compliance.

🛠️ Keahlian

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