Beamtherapeutics
Director, Regulatory CMC
Cambridge, MA. Posted a month ago
The role
The Director, Regulatory CMC will lead regulatory activities to support high quality CMC sections of regulatory documentation. This person will prepare CMC and Quality related health authority agency correspondence and regulatory applications for global products.
What you will do
- Provide regulatory CMC strategic leadership within Regulatory and on cross-functional teams
- Develop and proactively communicate regulatory CMC strategies, risks and key issues
- Act as the regulatory CMC lead and department representative in matrix teams
- Support development of manufacturing, analytical, and supply chain strategies
- Define CMC content requirements for quality sections of regulatory dossiers
- Plan and manage activities for the preparation of global regulatory submission elements
- Provide critical review of detailed scientific information described in CMC documents
- Evaluate CMC-related change proposals for regulatory impact and filing requirements
- Develop regulatory processes and procedures to support CMC components of regulatory submissions
- Lead and support global health authority interactions for CMC-related topics
Required qualifications
- BS degree in a scientific/engineering discipline
- Typically 12+ years of in the biotech industry with 9+ years experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) with direct technical writing expe
- Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines
- Strong experience with CTD format and content regulatory filings
- Excellent organizational, written/oral communication, and time management skills
- Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance)
Nice to have
- Experience with cell and gene therapy and/or lipid nanoparticles is desirable
- Diverse experience including biologics in the cell therapy space, drugs, and international filings preferred
About the company
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. The company uses base editing technology to advance a diversified portfolio of base editing programs.