Director of Regulatory Affairs

Join PT Global Health Solutions Indonesia, a leading healthcare and pharmaceutical company committed to innovation and compliance. We are seeking a Director of Regulatory Affairs to lead our regulatory strategy in Bangka Belitung and ensure adherence to local and international regulations. This role is crucial for maintaining our compliance with health and safety standards, ensuring our products meet regulatory requirements, and driving our strategic initiatives in the region.

As the Director of Regulatory Affairs, you will oversee all regulatory activities, manage relationships with regulatory bodies, and ensure our operations are in full compliance with local and international laws. You will work closely with cross-functional teams to develop and implement regulatory strategies that support our business goals. This is an exciting opportunity to make a significant impact in the healthcare industry while advancing your career in a dynamic and supportive environment.

📋 Tanggung Jawab Pekerjaan

• Oversee all regulatory activities and ensure compliance with local and international regulations.
• Manage relationships with regulatory bodies, including BPOM, KEMENKES, and other relevant authorities.
• Develop and implement regulatory strategies that support business goals and ensure compliance.
• Monitor and report on regulatory changes and their impact on our operations.
• Lead and mentor a team of regulatory affairs professionals.
• Ensure all products and operations meet regulatory requirements and standards.
• Collaborate with cross-functional teams to address regulatory challenges and opportunities.
• Represent the company in regulatory meetings and conferences.

🎓 Kualifikasi & Syarat

• Bachelor's degree in Pharmacy, Life Sciences, or a related field.
• Minimum of 10 years of experience in regulatory affairs, with at least 5 years in a leadership role.
• Proven experience in managing regulatory compliance and strategy.
• Strong knowledge of Indonesian regulatory requirements, including BPOM and KEMENKES regulations.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in English and Bahasa Indonesia.
• Certification in regulatory affairs or a related field is a plus.

🛠️ Keahlian

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