Deskripsi Pekerjaan
Join Cekindo Business International as a Regulatory Affairs Team Leader and spearhead our mission to navigate complex regulatory landscapes across diverse industries. In this pivotal role, you'll lead strategic initiatives for product registration, compliance management, and regulatory strategy development. You'll oversee cross-functional teams ensuring adherence to local and international regulations while driving innovation in healthcare and medical sectors. This position offers the opportunity to shape regulatory frameworks, liaise with government authorities, and lead high-impact projects that bring life-changing products to market. If you're a strategic thinker passionate about regulatory excellence and team leadership, we invite you to contribute to our dynamic environment where your expertise will directly influence market access and compliance success.
Tanggung Jawab
- Lead and mentor a team of regulatory affairs professionals in executing product registration strategies
- Develop comprehensive compliance frameworks for healthcare and medical industry products
- Manage end-to-end regulatory projects across multiple industries and geographies
- Liaise with government agencies including BPOM and other regulatory authorities
- Monitor regulatory changes and update internal compliance protocols
- Prepare and submit regulatory documentation with 100% accuracy
- Collaborate with R&D, legal, and quality teams to align regulatory requirements
- Represent the company at industry forums and regulatory working groups
Kualifikasi
- Bachelor's degree in Pharmacy, Life Sciences, or related field (Master's preferred)
- Minimum 5+ years in regulatory affairs with 2+ years in team leadership
- Proven experience with healthcare/medical product registration in Indonesia
- Deep knowledge of BPOM regulations and international compliance standards
- Exceptional project management and stakeholder communication skills
- Strong analytical abilities for interpreting complex regulatory requirements
- Fluency in English and Bahasa Indonesia (written and verbal)
- Certification in Regulatory Affairs (e.g., RAC) highly desirable