Global Head of Regulatory

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop a targeted regulatory strategy that aligns with company goals, customer needs, and feasible health-authority opportunities.

• Offer direction on global CMC lifecycle management, post-approval changes, reliance, work-sharing, and collaborative reviews.

• Evaluate dossier discrepancies, local regulations, reference approvals, and submission timelines for assessing project viability.

• Interpret regulatory advancements into actionable recommendations for clients, product priorities, and market potentials.

• Facilitate additional specialist or local expertise as required.

• Participate in customer discovery and executive discussions.

• Assist clients in identifying appropriate products, modifications, markets, and adoption strategies.

• Define regulatory feasibility, assumptions, dependencies, and success metrics alongside Solution Engineering.

• Create evidence-based business cases that connect regulatory collaboration with operational efficacy, supply continuity, approval timelines, and business value.

• Aid in acquisition, expansion, and renewal discussions by providing regulatory insights.

• Collaborate with Regulatory Engagement colleagues and regional leaders to ensure health-authority participation.

• Support dialogues with authorities, industry organizations, and collaborative initiatives.

• Help sponsors and authorities reach agreements on review strategies, information-sharing frameworks, and milestones.

• Transform expressions of interest into clear next steps with stakeholders and dependencies.

• Integrate authority feedback into client planning and platform development.

• Offer senior regulatory guidance during project execution and address customer-value obstacles.

• Assist in transitioning from pilots to sustainable operational use.

• Document project results, lessons learned, and referenceable evidence.

• Create playbooks for project selection, reliance readiness, authority engagement, and regulatory inquiries.

• Convert sponsor and regulator workflows into product requirements and priorities.

• Review demos, proposals, presentations, and external documents for regulatory accuracy.

• Provide regulatory leadership in customer forums.

• Represent Accumulus Technologies in industry and regulatory discussions.

• Enhance internal capability through coaching, training, and reusable guidance.

• Report to the Chief Commercial Officer while collaborating across Commercial, Solution Engineering, Customer Success, Delivery, Regulatory Engagement, and Product.

⛳️ Requirements

• Extensive senior-level experience in life sciences regulatory affairs.

• Profound practical knowledge in global CMC and lifecycle management.

• Proven history of leading intricate submissions or post-approval modifications across various markets.

• Direct interaction with health authorities.

• Hands-on experience with regulatory reliance, collaborative reviews, or regulatory modernization initiatives.

• Established credibility with senior leaders in regulatory, quality, manufacturing, and supply chain sectors.

• Experience in translating regulatory strategy into operational changes, preferably involving digital workflows, regulatory information management, or cloud collaboration.

• Commercial acumen to evaluate project value, test assumptions, and recognize impractical approaches.

• Excellent communication, sound judgment, and the ability to influence across functions without relying on hierarchy.

• Willingness to engage directly with customer issues in a lean, expanding organization.

• Openness to international travel as necessary.

• A degree in a relevant scientific field or equivalent professional experience.

• Advanced qualifications are preferable.

🏝️ Benefits

• International travel as needed.

• Advanced qualifications are preferred (not a compensation benefit).