Director - US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs

📋 Description

• Lead the US Regulatory Affairs CMC team, establishing priorities, guiding performance, and ensuring
• Develop and implement US CMC regulatory strategies for veterinary pharmaceutical products
• Oversee the preparation, review, and submission of CMC documentation for US regulatory
• Provide regulatory oversight for approved products, ensuring ongoing CMC compliance and effective
• Support manufacturing and supply initiatives, including technology transfers, site strategy
• Lead global CMC regulatory innovation for small-molecule products, guiding strategy development and

🎯 Requirements

• Bachelor's, master's, or doctoral degree in a relevant scientific discipline, such as Biology
• Significant industry experience in CMC Regulatory Affairs, including substantial responsibility for
• Strong knowledge of US CMC regulations, regulatory guidance, FDA requirements, and health authority
• Experience developing regulatory strategies for pharmaceutical products, including post-approval
• Demonstrated experience planning, preparing, reviewing, and coordinating regulatory submissions and
• Experience with global CMC regulatory requirements and exposure to regulatory authorities across

🎁 Benefits

• Annual salary: $180,000–$230,000.
• Remote work: Fully remote position based in the United States.
• Employment type: Full-time.
• Competitive benefits package.
• Leadership and career impact.
• Global collaboration.