CMC Dossiers Leader

PhD, MS, or other university degrees in one of the areas of biopharmaceutical drug development (e.g. pharmaceutical chemistry, pharmacy, biology, biotechnology, biochemistry)
In depth and superior knowledge in pharmaceutical development is mandatory
5-10 years professional experience ideally in CMC development is required
Proven records of leading CMC dossier development for clinical trial application or market registration submission (i.e., BLA/MAA/NDA)

Develop dossier strategies to enable parallel development of CMC dossiers with CMC activities
Lead a dossier sub team comprising of SMEs from various CMC functions for dossier preparation
Provide authoring guidance, templates, regulatory storyline, tools, and way of working and resolve obstacles as they arise
Lead authoring process, conduct team/management reviews, and facilitate resolutions to comments
Ensure consistent information presented throughout CMC dossiers and with other modules
Prepare/write CMC summaries, introductions, reviewer guides, and regulatory documents based on available CMC data
Prepare and approve in Vault RIM the CMC sign-off sheet with the approved CMC documents
Share lessons learned across the organization and provide state of the art guidance for dossier requirements
Lead dossier activities with external partners and CDMOs
Support M&A, in licensing due diligence activities by assessing the CMC dossiers content
Review and/or approve CMC dossiers and act as CMC Dossier modality head delegate
Guide and train new CMC Dossier Leaders and manage apprentices or trainees, GIGs & CMC helping hands
Contribute to future digitalization & AI solutions in regulatory environment