Director, US RA CMC Team Leader – Innovation, Global CMC Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the US Regulatory Affairs CMC team, establishing priorities and facilitating the delivery of regulatory strategies and submissions.

• Provide strategic leadership in US CMC regulatory matters throughout development and lifecycle activities.

• Supervise the preparation, review, and submission of CMC sections for US regulatory applications, amendments, supplements, and responses to inquiries from health authorities.

• Collaborate with Global CMC Regulatory Affairs colleagues and cross-functional teams, including technical development, manufacturing, quality, and supply.

• Advise project teams on US regulatory requirements, associated risks, and potential opportunities.

• Foster and enhance innovation within CMC regulatory processes, tools, and methodologies.

• Represent the organization in engagements with US health authorities.

• Monitor updates in US CMC regulations and guidance, and convey pertinent developments.

• Develop team capabilities through coaching, providing feedback, and sharing knowledge.

• Support veterinary pharmaceuticals from development through lifecycle management, encompassing technology transfers, site strategy, manufacturing changes, product/process enhancements, and global CMC strategies for innovation and registration preparation.

⛳️ Requirements

• Extensive experience in CMC Regulatory Affairs, including significant expertise in supporting US regulatory submissions and product lifecycle activities.

• Strong understanding of US CMC regulations, guidance, and expectations from health authorities.

• Experience in leading, developing, or mentoring regulatory professionals and coordinating complex, cross-functional projects.

• Proven ability to shape regulatory strategy and deliver clear, risk-based advice on intricate CMC issues.

• Experience in managing submission planning, content review, and responses to inquiries from health authorities.

• A keen interest in promoting innovation and continuous improvement within regulatory processes and operations.

• Exceptional written and verbal communication skills, with the capability to influence and collaborate across various teams and organizational levels.

• Strong organizational abilities and the capacity to handle multiple priorities in a dynamic environment.

• Degree in Science (Biology, Biochemistry, Chemistry, Bioengineering, etc.), BS/MS/Ph.D. with considerable industry experience in CMC regulatory affairs and in CMC regulatory affairs innovation/product development.

• Regulatory exposure in global regions is essential.

🏝️ Benefits

• Competitive salary