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

• Minimum 8 years of experience in regulatory affairs and bachelor’s degree in a relevant discipline
• Expertise in global regulatory requirements and registration 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.