Fast growing Biotech company Biologics Licence Application Program Management About Our Client We are mandated by our client, an innovative biotech company based in Lausanne. Job Description BLA Program Management Build, own and continuously maintain the integrated BLA master plan from pre-BLA meeting preparation through submission, filing, review, potential inspections, labeling negotiations and post-action commitments with external BLA regulatory consultants and dossier delivery team. Ensure all five CTD module plans are appropriately planned and integrated, including US regional content, summaries/overviews, CMC, nonclinical, clinical and labeling. Maintain the respective authoring, review, approval and publishing calendar as part of the overall BLA master plan. Cross-functional Governance and Execution Establish and run the BLA Team, including meeting cadence, agendas, decision records and action logs. Prepare concise program updates for the CEO and Executive Committee, Board, and investors as appropriate. Health Authority Meeting, inspection response Readiness Establish and run the BLA Team, including meeting cadence, agendas, decision records and action logs. Prepare concise program updates for the CEO and Executive Committee, Board, and investors as appropriate. Coordinate operational preparation for Health Authority meetings, including briefing-book timelines, internal alignment, rehearsal, follow-up actions and agency-commitment tracking. Coordinate FDA pre-approval inspection readiness across internal teams, WuXi Biologics, analytical laboratories, CROs and clinical sites. Establish and maintain the review "war room" for rapid, high-quality responses to FDA information requests. The Successful Applicant The ideal candidate combines profound project management capabilities with hands-on leadership without authority skills and BLA delivery experience to deliver the right BLA-ready content, decisions, evidence, quality checks and inspection-readiness activities on time. Experience Proven track record of successfully coordinating cross-functional teams and external CRO/CDMO/vendor networks in a small or mid-sized biotech environment. Structured, decisive and hands-on. Turns a complex biologics submission into a clear, accountable plan without creating unnecessary process. Proven ability to lead complex cross-functional teams without authority. Collaborative but firm. Protecting functional ownership while ensuring program-level decisions and timelines are me Executive ready communicator. Provides concise, decision-oriented reporting to the Executive Committee, Board and external partners. Qualifications 10+ years in biotech/pharma program management, development operations, regulatory project management, or submission management BLA delivery experience from pre-submission through review and approval is strongly preferred. Strong familiarity with CTD design and submissions, FDA meeting preparation, information-request management, and inspection readiness a plus Strong Project Management skills Excellent written and spoken English required. What's On Offer Permanent position Quote job ref: JN- #J-18808-Ljbffr
Program Management Director - BLA Arbeitgeber: Michael Page
Unser Mandant ist ein hervorragender Arbeitgeber, der eine moderne Unternehmenskultur mit flachen Hierarchien und kurzen Entscheidungswegen bietet. Die Finanzabteilung spielt eine zentrale Rolle in der Unternehmenssteuerung und ermöglicht den Mitarbeitenden vielfältige Entwicklungsmöglichkeiten in einem internationalen Umfeld. Mit flexiblen Arbeitszeiten, einem attraktiven Gehaltspaket und zahlreichen Corporate Benefits ist das Unternehmen ein idealer Ort für Fachkräfte, die eine sinnstiftende und abwechslungsreiche Tätigkeit suchen.
