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Visium

Business Development Director, Regulatory Affairs

Visium

Business Development Director leading commercial activities for AI platform in regulatory affairs. Help enterprise clients transform their regulatory document workflows in Life Sciences.

Posted 5/26/2026full-timeBarcelona • 🇪🇸 SpainLeadWebsite

About the role

Key responsibilities & impact
  • Lead the identification, engagement, and acquisition of new enterprise clients in pharmaceuticals, biotechnology, medtech, and regulatory affairs functions within healthcare organisations.
  • Develop and execute strategic outbound initiatives, including executive-level networking within regulatory and quality affairs communities, thought leadership engagements, and targeted outreach to heads of Regulatory Affairs, CMC, and Clinical Operations.
  • Qualify and prioritise opportunities to align Visium's Scribe platform with client submission timelines, document automation needs, and compliance objectives.
  • Conduct discovery meetings with VP/Head-level Regulatory Affairs, Quality, and R&D stakeholders to understand submission bottlenecks, authoring inefficiencies, and compliance requirements across FDA, EMA, and GxP frameworks.
  • Shape tailored proposals and presentations that demonstrate how Scribe accelerates regulatory document production — from CTD modules and CSRs to APQRs and GVDs — while keeping human experts in full control of every submission.
  • Collaborate with Visium's delivery and product teams to ensure successful onboarding, configuration to client templates and data systems, and measurable impact on authoring time and submission lead times.
  • Maintain deep knowledge of the regulatory affairs landscape, including evolving FDA and EMA guidance, industry trends in AI-assisted document workflows, and the competitive environment for regulatory technology solutions.
  • Mentor and develop junior business development and client engagement professionals, building commercial acumen and domain expertise in regulatory affairs and Life Sciences.
  • Drive a culture of collaboration across sales, delivery, and marketing teams to maximise client impact and grow Scribe's presence in the market.
  • Define performance goals, track pipeline progress, and share market insights to continuously optimise team effectiveness and go-to-market strategy.

Requirements

What you’ll need
  • 6–8 years of experience in business development, client engagement, or strategic consulting within the Life Sciences sector, with direct exposure to regulatory affairs, quality, or clinical functions.
  • Proven ability to drive enterprise client acquisition and revenue growth in complex, regulated industries, ideally with experience selling software, AI, or technology solutions into regulatory or quality teams.
  • Strong understanding of regulatory submission processes, document types (CTD, CSR, APQR, GVD), and compliance frameworks (FDA, EMA, GxP).
  • Excellent communication, presentation, and relationship-building skills with VP and C-level stakeholders in regulated environments.
  • Entrepreneurial mindset, strategic thinker, and highly results-oriented, comfortable operating in a fast-growing, product-led company.
  • Fluent in English; German or French is considered a strong plus given Visium's European client base.

Benefits

Comp & perks
  • A competitive compensation package
  • A yearly education budget to steep your learning curve
  • A yearly sport budget because a fit body leads to a fit mind
  • A flexible working culture because your work-life balance matters to us
  • A position that enables you to have an impact on 1’000s of people, and the whole company's growth.
  • An international, knowledgeable, and passionate team with a strong collaborative mindset.

ATS Keywords

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Hard Skills & Tools
business developmentclient engagementstrategic consultingregulatory submission processesdocument typescompliance frameworkssoftware salesAI technology solutionsregulatory technology solutionsdata systems
Soft Skills
communication skillspresentation skillsrelationship-building skillsentrepreneurial mindsetstrategic thinkingresults-orientedmentoringcollaborationcommercial acumenteam effectiveness