Director, US RA CMC – Innovation & Strategy Lead

Dechra; Boston (MA); Vor Ort; USD 180.000 - 260.000; Vollzeit

Zusammenfassung

Dechra is seeking a Director – US RA CMC Team Leader & Innovation to lead the CMC Regulatory Affairs team, drive US regulatory submissions, lifecycle management, and post-approval strategy for FDA and international markets.

You will coordinate with Global CMC Regulatory Affairs, manufacturing, quality, and external partners to ensure compliant strategies across regions and continuous process improvements.

Qualifikationen

• Extensive experience in CMC Regulatory Affairs including US submissions and lifecycle activities.
• Strong knowledge of US CMC regulations and health authority expectations.
• Experience leading regulatory professionals and coordinating cross-functional work.
• Ability to shape regulatory strategy with risk-based guidance on CMC matters.
• Experience managing submission planning, content reviews, and responses to health authorities.
• Interest in driving innovation and continuous improvement in regulatory processes.
• Excellent written and verbal communication and collaboration across teams.
• Strong organizational skills for multiple priorities in a changing environment.
• A degree in Science; advanced degree is an advantage.

Aufgaben

• Lead the US Regulatory Affairs CMC team and deliver high-quality regulatory strategies.
• Provide strategic US CMC regulatory leadership across development and lifecycle activities.
• Oversee preparation, review and submission of CMC sections for US regulatory applications.
• Partner with Global CMC Regulatory Affairs and cross-functional teams to align plans.
• Advise project teams on US regulatory requirements, risks and opportunities.
• Build and advance innovation in CMC regulatory processes and tools.
• Represent the organisation in interactions with US health authorities.
• Monitor changes in US CMC regulations and communicate developments to stakeholders.
• Develop team capabilities through coaching, feedback and knowledge sharing.

Kenntnisse

CMC Regulatory Affairs

US Regulatory Submissions

Regulatory Strategy

Team Leadership

Cross-functional Collaboration

Risk Assessment

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, drive US regulatory submissions, lifecycle management, and post-approval strategy for FDA and international markets.

You will coordinate with Global CMC Regulatory Affairs, manufacturing, quality, and external partners to ensure compliant strategies across regions and continuous process improvements.