Director, US RA CMC & Global Innovation Lead

Dechra; United States; Vor Ort; USD 180.000 - 290.000; Vollzeit

Zusammenfassung

Dechra is seeking a Director – US RA CMC Team Leader & Innovation to lead the CMC Regulatory Affairs team responsible for FDA considerations, lifecycle management, and post-approval strategies for veterinary medicines.

The role includes oversight of technology transfers, site strategy, manufacturing changes, and global CMC innovation across regions, interfacing with multiple departments to ensure compliant regulatory execution and quality standards.

Qualifikationen

• Extensive experience in CMC Regulatory Affairs and lifecycle management.
• Experience supporting US regulatory submissions and health authority interactions.
• Proven ability to lead regulatory professionals and coordinate cross-functional teams.
• Strong strategic mindset with risk-based advice on CMC matters.

Aufgaben

• Lead the US Regulatory Affairs CMC team, setting priorities and delivering high-quality regulatory strategies.
• Provide strategic US CMC regulatory leadership across development and lifecycle activities.
• Oversee the preparation, review and submission of CMC sections for US applications and responses.
• Partner with Global CMC Regulatory Affairs and cross-functional teams to align regulatory plans.
• Advise project teams on US regulatory requirements, risks and opportunities.
• Advance innovation in CMC processes, tools and ways of working.
• Represent the organization in interactions with US health authorities.

Kenntnisse

Regulatory strategy

US CMC

Team leadership

Submissions planning

Cross-functional

Regulatory compliance

Communication skills

Regulatory innovation

Ausbildung

BS/MS/PhD in Science

Jobbeschreibung

Dechra is seeking a Director – US RA CMC Team Leader & Innovation to lead the CMC Regulatory Affairs team responsible for FDA considerations, lifecycle management, and post-approval strategies for veterinary medicines.

The role includes oversight of technology transfers, site strategy, manufacturing changes, and global CMC innovation across regions, interfacing with multiple departments to ensure compliant regulatory execution and quality standards.