Program Management Director - BLA

- Fast growing Biotech company - Biologics Licence Application Program Management

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, CMO, 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.

- 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