Senior Regulatory Affairs Specialist

📋 Description

• Lead global regulatory submissions for product registrations and variations
• Develop regulatory strategies for new product development and market entry
• Advise cross-functional teams on global compliance requirements
• Oversee preparation of technical files and documentation for audits
• Manage agency communications for complex product approvals
• Provide expert guidance in interpretation of international regulations

🎯 Requirements

• 8+ years regulatory affairs experience; bachelor’s degree in a relevant field
• Expertise in global regulatory requirements and submission processes
• Advanced project leadership and communication skills
• Technical documentation review and approval capabilities
• Agency negotiation and strategic planning proficiency
• Experience with audits, submissions, and training

🎁 Benefits

• On-site weekly work schedule as defined by leader
• Equal opportunity employer with inclusive policies
• Market-competitive compensation and benefits