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

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $180k - $230k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 13%

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DECA

WebsiteLinkedInAll Job Openings

11 - 50 employees

💼 Consulting

💸 Finance

🤝 B2B

Consulting • Finance • B2B

DECA is a Puerto Rico–based advisory firm that helps companies navigate the island’s incentives, tax, compliance, and capital-access programs. It uses a technology-driven, analytics-backed approach to streamline processes and maximize available monetary incentives. Core services include entity foundational set-up, incentives decree applications, ongoing compliance and tax advisory, and access-to-capital solutions such as monetizable R&D and tourism tax credits, local cash grants for R&D and manufacturing, federal R&D grants, federal green energy credits (ITC/PTC), cash grant and tax credit bridge financing, equipment financing, working capital lines of credit, and building acquisition financing.

📋 Description

• Lead the US Regulatory Affairs CMC team, setting priorities and supporting delivery of 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 veterinary pharmaceuticals from development through lifecycle management, including technology transfers, site strategy, manufacturing changes, product/process improvements, and global CMC strategies for innovation and registration preparation

🎯 Requirements

• 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 • Degree in Science (Biology, Biochemistry, Chemistry, Bioengineering, etc.), BS/MS/Ph.D with significant industry experience in CMC regulatory affairs and in CMC regulatory affairs innovation/product development • Regulatory exposure in global regions is required

🏖️ Benefits

• Competitive salary