Dechra

Compliance

• Lead the US Regulatory Affairs CMC team, setting priorities and supporting delivery of high-quality regulatory strategies and submissions
• Provide strategic US CMC regulatory leadership across development and lifecycle activities
• Oversee preparation, review, and submission of CMC sections for US regulatory applications, amendments, supplements, and responses to health authority questions
• Partner with Global CMC Regulatory Affairs colleagues and cross-functional teams, including technical development, manufacturing, quality, and supply
• Advise project teams on US regulatory requirements, risks, and opportunities
• Build and advance innovation in CMC regulatory processes, tools, and ways of working
• Represent the organisation in interactions with US health authorities
• Monitor changes in US CMC regulations and guidance and communicate relevant developments
• Develop team capabilities through coaching, feedback, and knowledge sharing
• Support approved veterinary products, CMC compliance, lifecycle management, post-approval strategy, technology transfers, site strategy, manufacturing changes, product and process improvements, and global innovation strategies for pipeline programs

Explore Director – US RA CMC Team Leader, Global CMC Regulatory Affairs at Dechra. Review requirements and application details.

Open roles

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