Coordinate and manage OUS global regulatory teams for product registrations and variations.
Assist with regulatory strategies for OUS markets.
Advise cross-functional teams on global compliance requirements.
Provide expert guidance in interpretation of international regulations.
Represent regulatory affairs team in project meetings.
Review, approve, and update project documentation.

🎯 Requirements

8+ years of experience in regulatory affairs and bachelor’s degree in a relevant discipline, or
Experience with complex product submissions for Asia Pacific, Latin America and other OUS markets
OUS Agency negotiation and strategic planning proficiency.
Expertise in global regulatory requirements and registration processes.
Advanced project leadership and communication skills.
Technical documentation review and approval capabilities.

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