Senior Regulatory Affairs Specialist

📋 Description

• Develop regulatory strategies for new product development and market entry.
• Advise cross-functional teams on global compliance requirements.
• Lead regulatory submissions, agency communications and strategy for the US and Canada for complex
• Provide expert guidance in interpretation of international regulations.
• Represent regulatory affairs team in project meetings.
• Coordinate with OUS global regulatory teams for product registrations and variations.

🎯 Requirements

• 8+ years of experience in regulatory affairs and bachelor’s degree in a relevant discipline, or
• 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.
• Experience with audits, submissions, and training.

🎁 Benefits

• Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.