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

Dechra

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

Posted 11/4/2026full-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, compliance, and lifecycle management. Proven ability to lead teams, drive innovation in regulatory processes, and effectively communicate with cross-functional partners and health authorities.

Highest-signal resume keywords

CMC Regulatory Affairs LeadershipUS Regulatory Submissions ManagementCross-Functional Team CoordinationRegulatory Strategy DevelopmentInnovation in Regulatory Processes

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Regulatory AffairsUS CMC RegulationsSubmission PlanningContent ReviewRisk-Based Regulatory AdviceLifecycle ManagementTechnical DevelopmentManufacturing ChangesProduct DevelopmentProcess Improvements

Soft Skills

Excellent Communication SkillsOrganizational SkillsMentoring and CoachingCollaborationInfluencing Skills

Industry Keywords

Health Authority InteractionsRegulatory ComplianceVeterinary ProductsGlobal CMC Regulatory AffairsScientific DegreeBiologyBiochemistryChemistryBioengineeringRegulatory Exposure

About the role

Key responsibilities & impact

Lead the US Regulatory Affairs CMC team, setting priorities and supporting delivery of high-quality 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 approved veterinary products, CMC compliance, lifecycle management, post-approval strategy, technology transfers, site strategy, manufacturing changes, product and process improvements, and global innovation strategies for pipeline programs

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
Relevant scientific degree; BS/MS/Ph.D. in Science such as Biology, Biochemistry, Chemistry, or Bioengineering
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