Global Regulatory Operations Senior Executive APAC

ob Summary : The Regulatory Operations Specialist will be responsible for managing and executing regulatory strategies submissions and compliance activities across the Asia-Pacific (APAC) region. This role ensures that products meet all regulatory requirements for market access lifecycle management and post-market surveillance. The position involves cross-functional collaboration regulatory intelligence monitoring and direct engagement with health authorities. Key Responsibilities : Regulatory Strategy & Execution Develop and implement regulatory strategies for product registration and lifecycle management across and analyze regulatory changes and assess their impact on product internal stakeholders on regulatory requirements during development launch and post-approval phases. Regulatory Submissions & Compliance Prepare and manage regulatory dossiers for new products renewals and timely submission and approval of regulatory filings in compliance with local and international post-market activities including adverse event reporting product recalls and labeling compliance. Cross-Functional Collaboration Work closely with R&D Quality Legal and Commercial teams to align regulatory actions with business the company in meetings with regulatory agencies industry associations and external consultants. Regulatory Intelligence & Documentation Track emerging regulatory trends and provide proactive guidance to mitigate organized records of submissions approvals and regulatory reports and updates for internal stakeholders.

Required Experience :

Senior IC

Key Skills

Athletics,Corporate Banking,IT Management,Facilities,IT Support

Employment Type : Full-Time

Experience : years

Vacancy : 1