Business Development Director (Regulatory Affairs)

At Visium, we enable enterprise executives in defining their AI & Data strategy, execute large scale transformations and implement AI across operations, ensuring their organization becomes future-proof.

With expertise in strategy, architecture, cloud engineering, analytics, artificial intelligence and machine learning, we empower our clients to unleash and scale the power of their data.

We’re on a mission to pioneer a bright future and build future-proof and ethical organizations . Join the curious, the ambitious, the doers, the good-hearted, the ones who build a world we’re all in awe of – our Visumees.

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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.