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    Visium

    Business Development Director (Life Sciences - Regulatory Affairs)

    Visium
    Berlin1 month ago
    German nice-to-have
    Sales & Growth
    Business Development
    Leadership
    Hybrid

    Summary

    Business Development Director for Regulatory Affairs at Visium, an AI-native Life Sciences company. Drive growth for an AI agent platform for regulatory document drafting, requiring 6-8 years of Life Sciences BD/consulting experience and strong knowledge of regulatory affairs. Focus on acquiring enterprise clients in pharma/biotech.

    Location
    Berlin
    Type
    full-time
    Level
    Leadership
    Work mode
    hybrid

    Visium combines strategy, frontier AI, and deep regulated-industry expertise to build and deploy AI-native systems that reinvent how businesses operate - unlocking the value of AI at scale.

    We're not a strategy firm that ships slide decks and walks away. Not a tech consultancy that builds what won't get adopted. Not a product company chasing problems it doesn't understand. We're all three at once: strategy, deep technical and integration expertise, and product, working as one. That combination is our flywheel. Consulting keeps us close to the hardest real-world problems. Products let us solve them at scale. Every engagement sharpens our products; every deployment makes the next engagement faster, deeper, and more certain.

    We're obsessed with outcomes. While 95% of enterprise AI pilots never reach production, Visium is built to be the 5% delivering productised AI that compounds in value, not point solutions that deliver marginal gains. We are AI-native, not AI-adjacent. We don't bolt AI onto broken workflows; we redesign them with AI at the core.

    Role

    As Business Development Director for Regulatory Affairs, you will lead commercial activities for Visium's Scribe offering, an AI agent platform purpose-built for regulatory document drafting in Life Sciences. You will be the primary point of contact for pharmaceutical and biotech organisations looking to accelerate their regulatory submissions, reduce authoring time, and maintain full compliance with FDA, EMA, and GxP requirements.

    At Visium, you will play a pivotal role in driving the growth of Scribe, helping enterprise clients transform how their regulatory and quality teams produce CTD modules, CSRs, APQRs, and GVDs. This is a high-impact, entrepreneurial position where your deep understanding of the regulatory affairs landscape, combined with strong relationship-building and strategic sales skills, will directly shape how leading Life Sciences organisations adopt AI-driven document workflows.

    Responsibilities

    As a Business Development Director in Regulatory Affairs you will:

    Client Acquisition & Revenue Growth

    • 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.

    Solution Discovery & Client Alignment

    • 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.

    Leadership & Team Development

    • 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.

    To succeed in this role, you bring a combination of expertise, experience, and skills including:

    • 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.

    What we offer

    • 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.

    Check our LinkedIn and website to learn more about us & don’t hesitate to contact us if you have any questions.

    Business Development Director (Life Sciences - Regulatory Affairs)

    Visium · Berlin

    Apply for this role

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