Director - Us Ra Cmc Team Leader & Innovation, Global Cmc Regulatory Affairs

Welcome to Dechra

Dechra is an international veterinary pharmaceutical business focused on specialty products. We develop, manufacture, sell and market high-quality products exclusively for veterinarians around the world.

The salary range for this role will be applied based on the individual's skills, qualifications, experience, and other job-related criteria, in accordance with applicable law.

Job Purpose

The Director – US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs is responsible for leading the CMC Regulatory Affairs team with a focus on approved product, CMC compliance, lifecycle management, and post-approval regulatory strategy for FDA and internationally approved veterinary pharmaceuticals.

KEY RESPONSIBILITIES

• Lead the US Regulatory Affairs CMC team, setting priorities and supporting the team’s delivery of high-quality regulatory strategies and submissions.

• Provide strategic US CMC regulatory leadership across development and lifecycle activities, ensuring regulatory requirements are considered throughout product planning.

• Oversee the 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, to align regulatory plans and business objectives.

• Advise project teams on US regulatory requirements, risks and opportunities, and recommend practical approaches to address complex CMC issues.

• Build and advance innovation in CMC regulatory processes, tools and ways of working to improve effectiveness, consistency and quality.

• Represent the organisation in interactions with US health authorities, contributing to meeting preparation, regulatory discussions and follow-up activities.

• Monitor changes in US CMC regulations and guidance, assess their impact and communicate relevant developments to stakeholders.

• Develop team capabilities through coaching, feedback and knowledge sharing, while fostering a collaborative and accountable working environment.

SKILLS & EXPERIENCE

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

• Strong knowledge of US CMC regulations, guidance and health authority expectations.

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

• Demonstrated ability to shape regulatory strategy and provide clear, risk-based advice on complex CMC matters.

• Experience managing submission planning, content review and responses to health authority questions.

• Interest in driving innovation and continuous improvement in regulatory processes and operations.

• Excellent written and verbal communication skills, with the ability to influence and collaborate across teams and levels of an organisation.

• Strong organisational skills and the ability to manage multiple priorities in a changing environment.

• A relevant scientific degree; an advanced degree is an advantage.

Qualifciations