Global Head of Regulatory

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Accumulus Technologies

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2025

☁️ SaaS

🏥 Healthcare

💊 Pharmaceuticals

SaaS • Healthcare • Pharmaceuticals

Accumulus Technologies is a SaaS-based cloud platform that connects the healthcare ecosystem to streamline regulatory information exchange across sponsors, regulators, and other stakeholders. The platform focuses on digitizing dossier management, enabling real-time, secure submissions and collaboration throughout the drug development lifecycle to accelerate regulatory decisions and access to medicines. Accumulus positions itself as a tool to reduce timelines and costs associated with global regulatory submissions and to replace siloed document-based workflows with a single connected system.

📋 Description

• 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

• 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

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

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume