Global Head of Regulatory

Accumulus Technologies

About The Position

Accumulus Technologies is seeking a senior regulatory leader to turn regulatory innovation into routine use. Reporting to the Chief Commercial Officer, the Global Head of Regulatory is the company’s principal regulatory subject matter expert, connecting customer needs, health authority expectations, and platform capabilities. The role currently focuses on Chemistry, Manufacturing and Controls (CMC), post-approval changes, regulatory reliance, and collaborative review, with potential to support initial marketing authorisations and other agreed use cases as the company expands. This is a hands-on leadership role involving direct work with customers and regulators. The role helps select and shape viable projects, resolve regulatory barriers, and guide colleagues across Commercial, Solution Engineering, Customer Success, Delivery, and Product. The goal is to advance well-qualified sponsor projects into active use, achieve measurable customer value, and encourage repeat adoption. The role owns regulatory judgement, strategy, and the quality of regulatory guidance. It works across teams to ensure proposed projects are feasible, commitments are credible, and regulatory issues have clear ownership. Sales owns account strategy and commercial negotiations; Solution Engineering owns solution scoping; Regulatory Engagement leads authority relationships and regional activation; Customer Success and Delivery own adoption and execution within their respective remits; and Product owns the platform roadmap and technical implementation. Sponsors remain responsible for their submissions, and health authorities retain their decision-making authority.

Requirements

Substantial senior-level experience in life sciences regulatory affairs, with deep practical expertise in global CMC and lifecycle management.
A track record of leading complex submissions or post-approval changes across multiple markets and engaging directly with health authorities.
Practical experience with regulatory reliance, collaborative review, or initiatives to modernise regulatory processes.
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 judgement, including the ability to assess where projects can create value, where assumptions need testing, and where proposed approaches are unlikely to work.
Clear communication, sound judgement, and the ability to influence across functions without relying on hierarchy.
Willingness to work directly on customer issues in a lean, growing organisation and travel internationally as required.
A degree in a relevant scientific discipline or equivalent professional experience.

Nice To Haves

An advanced qualification.

Responsibilities

Set a focused regulatory strategy aligned with company priorities, customer demand, and realistic opportunities for health authority participation.
Provide guidance on global CMC lifecycle management, post-approval changes, reliance, work-sharing, and collaborative review.
Assess how dossier differences, local requirements, reference approvals, and submission timing affect project feasibility.
Translate regulatory developments into recommendations for customers, product priorities, and market opportunities.
Identify where specialist or local expertise is needed and coordinate that input.
Join priority discovery and executive discussions to understand customers’ regulatory objectives, operational constraints, and decision criteria.
Help customers select suitable products, changes, and markets, and define a credible route from an initial project to broader adoption.
Work with Solution Engineering to establish regulatory feasibility, assumptions, dependencies, and success measures before commitments are made.
Help 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, practical examples, and responses to objections.
Work with Regulatory Engagement colleagues and regional leads to secure appropriate health authority participation in priority customer projects.
Provide regulatory substance for discussions with authorities, industry groups, and collaboration initiatives.
Help sponsors and authorities agree workable review approaches, information-sharing arrangements, and project milestones.
Convert expressions of interest into defined next steps with clear owners and dependencies.
Bring authority feedback into customer planning and platform development.
Provide senior regulatory guidance during project execution and help resolve issues that could delay or limit customer value.
Work with Customer Success and Delivery to support the transition from pilots to repeatable operational use.
Establish an approach to capturing project outcomes, lessons learned, and referenceable evidence, with customer permission.
Develop practical playbooks for project selection, reliance readiness, authority engagement, and common regulatory questions.
Translate sponsor and regulator workflows into clear requirements and priorities for Product.
Review priority demonstrations, proposals, presentations, and external materials for regulatory accuracy and relevance.
Provide regulatory leadership for customer forums with focused agendas and actionable outputs.
Represent Accumulus Technologies in selected industry and regulatory forums.
Build internal capability through coaching, training, and reusable guidance.