Deskripsi Pekerjaan
Join Morula IVF's leadership team as the Division Head of Medical & Regulatory Affairs and shape the future of healthcare compliance in Indonesia's rapidly growing fertility sector. This critical leadership position requires a strategic thinker with deep expertise in navigating complex healthcare regulations while driving operational excellence. You'll lead cross-functional teams to ensure adherence to national and international standards, develop innovative regulatory strategies, and serve as the primary liaison with government agencies. If you're passionate about advancing reproductive medicine through meticulous regulatory oversight and have a proven track record in healthcare compliance, this role offers an unparalleled opportunity to make a transformative impact on patient care and organizational growth.
Tanggung Jawab
- Develop and implement comprehensive regulatory strategies for medical products and services
- Lead regulatory affairs team in ensuring compliance with MOH, BPOM, and international standards
- Oversee preparation and submission of regulatory documentation and license renewals
- Monitor and interpret healthcare policy changes and advise executive leadership
- Manage relationships with government agencies and regulatory bodies
- Conduct internal audits and implement corrective action plans
- Collaborate with R&D and clinical teams to ensure regulatory compliance in product development
Kualifikasi
- Master's degree in Pharmacy, Medicine, Life Sciences, or related field (PhD preferred)
- Minimum 8-10 years regulatory affairs experience in healthcare/biotech sector
- Proven leadership experience managing regulatory teams and projects
- Deep knowledge of Indonesian healthcare regulations (BPOM, MOH) and international standards
- Professional certification in regulatory affairs (e.g., RAC) highly desirable
- Fluency in Bahasa Indonesia and English (written and verbal)
- Experience in IVF/ART regulatory environment preferred