Overview

The Manager, Regulatory Affairs Operations provides technical and operational leadership and strategic partnership for regulatory publishing and submission activities to global Health Authorities (e.g., FDA, Health Canada, and international agencies). This role is accountable for ensuring high-quality, compliant, and timely regulatory submissions across the product lifecycle, while driving process optimization, technical standards, and capability development within Regulatory Affairs Operations.

In addition to hands-on oversight of complex submissions, the Manager plays a key role in providing technical guidance and upskilling to cross-functional partners and vendors, and shaping the globalization and modernization of regulatory publishing processes in alignment with evolving Health Authority expectations and internal digital strategies.

Regulatory Submission & Technical Oversight

• Provides technical oversight and quality accountabilit...