This early stage biotech company is developing precision genetic medicines through base editing and cell therapies for the treatment of serious diseases. They are seeking a Regulatory CMC Director or Senior Director who can lead and execute CMC regulatory strategies for their programs in development. Reporting into the SVP of Regulatory, you will work with cross functional teams to advance their innovative genomic medicine programs. This company offers cutting-edge science, a values-driven company culture, and unlimited Paid Time Off. With their first program going into clinical trials this year and a strong cash position, now is an exciting time to join this growing organization.
- Provide regulatory CMC strategic leadership within Regulatory and on cross-functional teams to support development of innovative genomic medicines/cell therapies.
- Plan and manage activities for the preparation of high-quality CMC-related global regulatory submission elements, including authoring and/or critical review to ensure compliance with regulatory requirements, in accordance with program timelines.
- Define CMC content (data and documentation) requirements for quality sections of regulatory dossiers (IND/CTA/MF and BLA/MAA).
- Lead and support global health authority interactions for CMC-related topics including defining strategy, preparation, and meeting facilitation.
- Act as the regulatory CMC lead and department representative in matrix teams for development programs.
- Develop and proactively communicate regulatory CMC strategies, risks, and key issues in an evolving regulatory landscape.
- Support development of manufacturing, analytical, and supply chain strategies and provide expert regulatory guidance to enable global implementation.
- Providing critical review of detailed scientific information described in CMC documents and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data.
- Evaluation of CMC-related change proposals for regulatory impact and filing requirements; provide strategic regulatory guidance for optimal implementation of changes.
- Develop regulatory processes and procedures to support CMC components of regulatory submissions.
- Support the creation and maintenance of CMC submission templates and dossier standards.
- Support Quality Assurance in preparing and hosting GMP and pre-approval inspections.
- Develops and maintains collaborative partnerships with key internal and external stakeholders.
- Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global CMC regulations and guidance, and provide regulatory advice to CMC and project teams.
- Bachelors in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
- Ten or more years of industry experience with 6+ years in Regulatory CMC for novel products.
- Direct experience in preparing CMC sections for INDs, CTAs, BLAs, MAAs, etc) required.
- Must have regulatory CMC experience with biologics. Cell or gene therapy experience desired but not required.
- Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines; with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products.
- Ex-US experience desired but not required.
- Strong experience with CTD format and content regulatory filings.
- Excellent organizational, written/oral communication, and time management skills; ability to communicate complex issues in a succinct and logical manner; strong listening skills.
- Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- Ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders; flexibility in responding to changing priorities and/or unexpected events.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.