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

DECA

. Lead the US Regulatory Affairs CMC team, setting priorities and supporting delivery of regulatory strategies and submissions .

Posted 10/27/2026full-timeRemote • United StatesSenior💰 $180,000 - $230,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in CMC Regulatory Affairs, with a strong focus on US regulatory submissions and lifecycle management. Proven ability to lead teams, shape regulatory strategies, and drive innovation in regulatory processes.

Highest-signal resume keywords

CMC Regulatory AffairsUS Regulatory SubmissionsRegulatory Strategy DevelopmentTeam Leadership and MentoringKnowledge of US CMC Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Submission PlanningContent ReviewRisk-Based Regulatory AdviceLifecycle ManagementInnovation in Regulatory Processes

Soft Skills

Excellent Communication SkillsOrganizational SkillsCollaboration Skills

Industry Keywords

Veterinary PharmaceuticalsHealth Authority InteractionsGlobal CMC StrategiesRegulatory GuidanceCross-Functional Coordination

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Competitive salary