Global Head of Regulatory

Accumulus Technologies

. Set a focused regulatory strategy aligned with company priorities, customer demand, and realistic health-authority opportunities .

Posted 11/9/2026full-timeRemote • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in global CMC lifecycle management and regulatory affairs, with a strong ability to translate regulatory strategies into operational changes and business value. Proven track record in leading complex submissions and engaging with health authorities to drive project success.

Highest-signal resume keywords

Global CMC Lifecycle ManagementRegulatory Affairs ExpertiseComplex Submission LeadershipHealth Authority EngagementRegulatory Strategy Translation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory RelianceCollaborative ReviewRegulatory ModernizationRegulatory Information ManagementDigital WorkflowsProject Value AssessmentOperational Change ImplementationEvidence-Based Business CasesRegulatory Accuracy ReviewRegulatory Leadership

Soft Skills

Clear CommunicationSound JudgmentInfluencing SkillsCustomer FocusCoaching and Training

Tools & Technologies

Cloud CollaborationRegulatory Engagement Platforms

Certifications & Qualifications

Advanced Qualification

Industry Keywords

Life SciencesHealth AuthoritiesRegulatory StrategySupply ChainQuality Management

Tech Stack

Tools & technologies

Cloud

About the role

Key responsibilities & impact

Set a focused regulatory strategy aligned with company priorities, customer demand, and realistic health-authority opportunities
Provide guidance on global CMC lifecycle management, post-approval changes, reliance, work-sharing, and collaborative review
Assess dossier differences, local requirements, reference approvals, and submission timing for project feasibility
Translate regulatory developments into recommendations for customers, product priorities, and market opportunities
Coordinate additional specialist or local expertise when needed
Join customer discovery and executive discussions
Help customers identify suitable products, changes, markets, and adoption pathways
Establish regulatory feasibility, assumptions, dependencies, and success measures with Solution Engineering
Build evidence-based business cases linking regulatory collaboration to operational efficiency, supply continuity, approval timing, and business value
Support acquisition, expansion, and renewal discussions with regulatory insight
Work with Regulatory Engagement colleagues and regional leads to secure health-authority participation
Support discussions with authorities, industry groups, and collaboration initiatives
Help sponsors and authorities agree review approaches, information-sharing arrangements, and milestones
Convert expressions of interest into defined next steps with owners and dependencies
Bring authority feedback into customer planning and platform development
Provide senior regulatory guidance during project execution and resolve customer-value blockers
Support transition from pilots to repeatable operational use
Capture project outcomes, lessons learned, and referenceable evidence
Develop playbooks for project selection, reliance readiness, authority engagement, and regulatory questions
Translate sponsor and regulator workflows into Product requirements and priorities
Review demonstrations, proposals, presentations, and external materials for regulatory accuracy
Provide regulatory leadership for customer forums
Represent Accumulus Technologies in industry and regulatory forums
Build internal capability through coaching, training, and reusable guidance
Report to the Chief Commercial Officer and work across Commercial, Solution Engineering, Customer Success, Delivery, Regulatory Engagement, and Product

Requirements

What you’ll need

Substantial senior-level experience in life sciences regulatory affairs
Deep practical expertise in global CMC and lifecycle management
Track record of leading complex submissions or post-approval changes across multiple markets
Direct engagement with health authorities
Practical experience with regulatory reliance, collaborative review, or regulatory modernization initiatives
Credibility with senior regulatory, quality, manufacturing, and supply-chain leaders
Experience translating regulatory strategy into operational change, ideally involving digital workflows, regulatory information management, or cloud collaboration
Commercial judgment to assess project value, test assumptions, and identify unworkable approaches
Clear communication, sound judgment, and ability to influence across functions without relying on hierarchy
Willingness to work directly on customer issues in a lean, growing organization
Willingness to travel internationally as required
A degree in a relevant scientific discipline or equivalent professional experience
Advanced qualification desirable

Benefits

Comp & perks

International travel as required
Advanced qualification is desirable (not a compensation benefit)