International Regulatory Affairs Specialist

General Description

The International Regulatory Affairs Specialist is responsible for ensuring that products comply with international regulatory requirements across multiple regions. This role supports product registration, regulatory strategy, and compliance activities to enable global market access. This includes reviewing product chemistry, toxicology, and efficacy data, as well as verifying the accuracy and integrity of supporting scientific research. This role requires close collaboration with sales and marketing to support compliant product strategies and effectively prioritize and manage related projects.

Regulatory Strategy & Compliance

• Support development and execution of global regulatory strategies for product registration and lifecycle management
• Interpret and apply regulations across multiple regions
• Identify regulatory risks and opportunities, developing strategies to mitigate risks and enhance success rates

Registrations & Submissions

• Ensure timely preparation and submission of:
• Regulatory dossiers
• Registration applications and amendments
• Data compensation documentation

Cross-Functional Collaboration

• Partner with:
• R&D
• Product stewardship
• Marketing and commercial teams
• Provide regulatory guidance for:
• New product development
• Label claims and positioning
• Market entry strategies

Project Management

• Manage multiple regulatory projects simultaneously
• Establish priorities and ensure timely completion of deliverables
• Track regulatory milestones and maintain internal systems

Stakeholder Communication

• Communicate regulatory requirements and compliance expectations directly with customers, providing guidance on product use, labeling, and registration status across global markets