Regulatory Affairs Technical Lead

Primary Function of Position

This role leads regulatory initiatives for enterprise-wide products or platforms, drives regulatory strategy, and collaborates with executive and cross-functional teams for compliance and market expansion.

Essential Job Duties

• Develop global regulatory strategies for complex product portfolios.
• Advise executives and teams on regulatory risks, trends, and compliance options.
• Lead complex regulatory strategy, regulatory submissions, agency communications for the US and Canada.
• Lead response to major regulatory agency inquiries, inspections, and audits.
• Develop training materials on new regulations and regulatory changes.
• Review, approve and update project documentation.
• Track and analyze global regulatory changes and their impact on the business.
• Mentor regulatory team members.
• Coordinate with OUS global regulatory teams for product registrations and variations.
• Provide metrics, dashboards, and executive communication on regulatory efforts.
• Represent company in industry and regulatory forums.