Business Development Director (Life Sciences - Regulatory Affairs)

Darum lohnt es sich

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. /ppAt 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. /ppbResponsibilities /b /ppAs a Business Development Director in Regulatory Affairs you will: /ppbClient Acquisition Revenue Growth /b /pliLead the identification, engagement, and acquisition of new enterprise clients in pharmaceuticals, biotechnology, medtech, and regulatory affairs functions within healthcare organisations. /liliDevelop 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. /liliQualify and prioritise opportunities to align Visium's Scribe platform with client submission timelines, document automation needs, and compliance objectives. /lipbSolution Discovery Client Alignment /b /pliConduct discovery meetings with VP/Head-level Regulatory Affairs, Quality, and RD stakeholders to understand submission bottlenecks, authoring inefficiencies, and compliance requirements across FDA, EMA, and GxP frameworks. /liliShape 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. /liliCollaborate 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. /liliMaintain 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. /lipbLeadership Team Development /b /pliMentor and develop junior business development and client engagement professionals, building commercial acumen and domain expertise in regulatory affairs and Life Sciences. /liliDrive a culture of collaboration across sales, delivery, and marketing teams to maximise client impact and grow Scribe's presence in the market. /liliDefine performance goals, track pipeline progress, and share market insights to continuously optimise team effectiveness and go-to-market strategy. /lipbRequirements /b /ppTo succeed in this role, you bring a combination of expertise, experience, and skills including: /pli6–8 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. /liliProven 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. /liliStrong understanding of regulatory submission processes, document types (CTD, CSR, APQR, GVD), and compliance frameworks (FDA, EMA, GxP). /liliExcellent communication, presentation, and relationship-building skills with VP and C-level stakeholders in regulated environments. /liliEntrepreneurial mindset, strategic thinker, and highly results-oriented, comfortable operating in a fast-growing, product-led company. /liliFluent in English; German or French is considered a strong plus given Visium's European client base. /lipbBenefits /b /ppWhat we offer /pliA competitive compensation package /liliA yearly education budget to steep your learning curve /liliA yearly sport budget because a fit body leads to a fit mind /liliA flexible working culture because your work-life balance matters to us /liliA position that enables you to have an impact on 1’000s of people, and the whole company's growth. /liliAn international, knowledgeable, and passionate team with a strong collaborative mindset. /li ppbRole /b /p /ppAs 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.