US RA CMC Director & Innovation Lead

Dechra Pharmaceuticals PLC; Boston (MA); On-site; USD 190,000 - 270,000; Full time

Job summary

Dechra Pharmaceuticals PLC seeks a dynamic Director for the US RA CMC Team Leader & Innovation to lead regulatory strategy and submissions for FDA and international programs. You will guide lifecycle management, post-approval strategy, and regulatory innovation across multiple regions.

The role interfaces with global RA CMC, development, manufacturing, quality, and external CDMOs to ensure compliant execution, impactful strategy, and successful product launches.

Qualifications

• Extensive experience in CMC regulatory affairs with US submissions and lifecycle activities.
• Strong knowledge of US CMC regulations, guidance and health authority expectations.
• Proven ability to mentor regulatory professionals and manage cross-functional work.
• Ability to shape regulatory strategy and provide risk-based advice on CMC matters.
• Experience planning submissions and coordinating responses to health authorities.
• Interest in driving innovation and continuous improvement in regulatory processes.
• Excellent written and verbal communication, with influence across teams.

Responsibilities

• Lead the US Regulatory Affairs CMC team, setting priorities and ensuring high-quality strategies and submissions.
• Provide strategic US CMC leadership across development and lifecycle activities.
• Oversee preparation, review and submission of CMC sections for US regulatory applications.
• Collaborate with Global CMC colleagues, development, manufacturing, quality and supply.
• Advise project teams on US regulatory requirements, risks, opportunities and approaches.
• Advance innovation in CMC regulatory processes, tools and ways of working.
• Represent the organization in interactions with US health authorities and meetings.
• Monitor changes in US CMC regulations and communicate updates to stakeholders.
• Develop team capabilities through coaching and knowledge sharing.

Skills

CMC Regulatory Affairs

US Regulatory Submissions

Regulatory Strategy

Cross-functional Leadership

Lifecycle Management

Regulatory Communications

Innovation in Regulation

Team Coaching

Strategic Influence

Education

BS/MS/PhD in Science

Job description

Dechra Pharmaceuticals PLC seeks a dynamic Director for the US RA CMC Team Leader & Innovation to lead regulatory strategy and submissions for FDA and international programs. You will guide lifecycle management, post-approval strategy, and regulatory innovation across multiple regions.

The role interfaces with global RA CMC, development, manufacturing, quality, and external CDMOs to ensure compliant execution, impactful strategy, and successful product launches.