International Regulatory Affairs Executive

Join Yanling Natural Hygiene as an International Regulatory Affairs Executive and play a pivotal role in expanding our global footprint in the healthcare and medical industry. This position offers a unique opportunity to shape regulatory strategies, ensure compliance, and drive innovation in the region. Based in Canggu, you'll be part of a dynamic team working closely with international partners to navigate the complexities of global regulations.

As an International Regulatory Affairs Executive, you'll be responsible for developing and implementing regulatory strategies that align with Yanling's global expansion plans. You'll work with cross-functional teams to ensure our products meet international standards, and you'll collaborate with regulatory authorities in key markets to secure approvals and certifications. This role is perfect for a professional who thrives in a fast-paced, multi-cultural environment and is passionate about driving compliance and innovation in the healthcare industry.

📋 Tanggung Jawab Pekerjaan

• Develop and implement regulatory strategies to support Yanling's global expansion in the healthcare and medical industry.
• Work with cross-functional teams to ensure our products meet international standards and regulations.
• Collaborate with regulatory authorities in key markets to secure approvals and certifications.
• Monitor and assess regulatory changes and their potential impact on our business operations.
• Provide guidance and support to local teams on regulatory matters.
• Ensure compliance with international regulatory requirements and standards.
• Stay up-to-date with the latest developments in global regulatory affairs.
• Represent Yanling at industry conferences, forums, and events to build relationships and network with key stakeholders.

🎓 Kualifikasi & Syarat

• Bachelor's degree in Pharmacy, Regulatory Affairs, or a related field.
• Minimum of 5 years of experience in regulatory affairs, with a focus on international markets.
• Proven experience in developing and implementing regulatory strategies for global expansion.
• Strong understanding of international regulatory requirements and standards, including those from the FDA, EMA, and other relevant authorities.
• Excellent communication and interpersonal skills, with the ability to build relationships and influence stakeholders.
• Proficiency in English, with additional language skills an advantage.
• Familiarity with regulatory software and tools such as Regulatory Affairs Management Systems (RAMS) and electronic submission systems.
• Certification in regulatory affairs or a related field is a plus.

🛠️ Keahlian

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