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 APAC.Monitor and analyze regulatory changes and assess their impact on product portfolios.Advise 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 variations.Ensure timely submission and approval of regulatory filings in compliance with local and international regulations.Oversee 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 goals.Represent 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 risks.Maintain organized records of submissions, approvals, and correspondence.Prepare regulatory reports and updates for internal stakeholders.