APAC Regulatory Lead
Job Description
Clinexa is a Clinical Research Organization (CRO) dedicated to supporting pharmaceutical, biotechnology, and healthcare partners in the successful delivery of clinical trials and research programs. The company fosters a collaborative and fast-paced environment where professionals are empowered to contribute to innovative research, uphold high standards of quality and compliance, and grow their careers within the evolving clinical research and life sciences industry.
The APAC Regulatory Lead is responsible for leading regional regulatory activities across Asia-Pacific markets to support product registrations, lifecycle management, and regulatory compliance within the pharmaceutical, biotechnology, medical device, or healthcare industry. The role involves developing regulatory strategies, managing submissions and approvals, coordinating with health authorities, and ensuring compliance with regional regulatory requirements and global standards.
The successful candidate will collaborate closely with cross-functional teams including Medical Affairs, Clinical Operations, Quality Assurance, Pharmacovigilance, Manufacturing, and Commercial teams to support product launches and ongoing market activities across APAC countries. Strong knowledge of regional regulatory frameworks, stakeholder management, and experience handling multi-country regulatory submissions within regulated healthcare environments are essential for this role.
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