Program Management Director - Biologics Licence Application (BLA)

About the role

A fast-growing biotech company based in Lausanne is looking for a Program Management Director to build, own and maintain its integrated BLA master plan, from pre-submission preparation through submission, filing, review, potential inspections, labeling negotiations and post-action commitments. The role works closely with external BLA regulatory consultants and the dossier delivery team.

Key responsibilities

• Build and maintain the integrated BLA master plan, covering the five CTD modules (US regional content, summaries, CMC, nonclinical, clinical and labeling)
• Maintain the authoring, review, approval and publishing calendar as part of the BLA master plan
• Establish and run the BLA team, including meeting cadence, agendas, decision records and action logs
• Prepare concise program updates for the CEO, Executive Committee, Board and investors
• Coordinate operational preparation for Health Authority meetings, including briefing-book timelines, internal alignment, rehearsal and follow-up
• Coordinate FDA pre-approval inspection readiness across internal teams, CMO, analytical laboratories, CROs and clinical sites
• Run a review war room for rapid, high-quality responses to FDA information requests

Required profile

• 10+ years in biotech/pharma program management, development operations, regulatory project management or submission management
• Proven track record coordinating cross-functional teams and external CRO/CDMO/vendor networks in a small or mid-sized biotech environment
• Experience leading complex cross-functional teams without authority; collaborative but firm
• Executive-ready communicator who reports concisely to the Executive Committee, Board and external partners
• Excellent written and spoken English

Required skills

• Strong project management skills
• Familiarity with CTD design and submissions, FDA meeting preparation, information-request management and inspection readiness is a plus

The position is permanent.