Save Job Back to Search Job Description Summary Similar JobsLead US IND strategy with direct FDA engagementHigh-impact role ahead of global trial in 2027About Our ClientOur client is a venture-backed biotechnology platform headquartered in Singapore, focused on acquiring and advancing high-potential therapeutic assets for global development. The organisation operates as a strategic bridge across multiple geographies, including the US and Asia, progressing programmes through key clinical and regulatory milestones.Backed by a leading global life sciences investor with a strong track record in building successful biotech companies, the business adopts a lean operating model supported by external partners and CROs. With a growing pipeline and plans for global clinical trials beginning in 2027, the company is entering a critical phase of development and scaling its leadership team accordingly.Job DescriptionLead the design and execution of global regulatory strategies across pipeline assetsDrive US IND submissions and manage direct interactions with FDA and other health authoritiesProvide hands-on oversight of day-to-day regulatory operations and submissionsCollaborate cross-functionally to align regulatory strategy with clinical development plansManage external CROs, consultants, and global regulatory partnersSupport due diligence and regulatory assessment for in-licensing opportunitiesEnsure regulatory compliance, risk mitigation, and inspection readiness across programmesThe Successful ApplicantA successful Director of Regulatory Affairs should have:10+ years of experience in regulatory affairs within biotech or pharmaceuticalsProven track record leading IND submissions and engaging with the FDAStrong background in global regulatory strategy across multiple regionsExperience operating in lean or early-stage biotech environmentsDemonstrated ability to work both strategically and hands-onTrack record of managing CROs and external regulatory partnersExperience supporting cross-border development programmesWhat's on OfferThis is an opportunity to join a high-growth biotech platform at a pivotal stage, where you will play a central role in enabling global clinical development and regulatory success. The position offers significant ownership, exposure to senior leadership, and the chance to shape regulatory strategy from the ground up. You will work in a collaborative, entrepreneurial environment with strong investor backing, alongside a competitive compensation structure and long-term value creation potential.ContactAnurag Garg (Lic No: R1215997 / EA No:18S9099)Quote job refJN-072026-7062799Phone number+65 6416 9817Job summaryFunctionLife SciencesSpecialisationRegulatory AffairsWhat is your area of specialisation?Healthcare / PharmaceuticalLocationSingaporeContract TypePermanentConsultant nameAnurag Garg (Lic No: R1215997 / EA No:18S9099)Consultant contact+65 6416 9817Job ReferenceJN-072026-7062799
