Maya Miatkowski

Experience

1. Manager, Cmc Regulatory

   Beam Therapeutics

   Jan 2023 — Present

   Contributing regulatory CMC strategic direction within Regulatory and cross-functional teams for development of genomic medicines/cell therapies • Helping to develop and communicate regulatory CMC strategies, risks and key issues • Providing support to the regulatory CMC lead and department representative • Supporting development of manufacturing, analytical, and supply chain strategies and providing expert regulatory guidance to enable global implementation • Defining CMC content requirements for quality sections of regulatory dossiers (IND/CTA/MF and BLA/MAA) • Preparation of high-quality CMC-related global regulatory submission elements, including authoring and/or critical review • Providing critical review of detailed scientific information described in CMC documents and assessing technical portions • Evaluation of CMC-related change proposals for regulatory impact and filing requirements; provide strategic regulatory guidance for optimal implementation of changes • Helping to develop regulatory processes and procedures to support CMC components of regulatory submissions • Contributing to the creation and maintenance of CMC submission templates and dossier standards • Involved in global health authority interactions for CMC-related topics including helping to define strategy, preparation, and meeting facilitation • Support for Quality Assurance in preparing and hosting GMP and pre-approval inspections • Participating in regulatory intelligence activities, monitoring regulatory guidelines & trends as they pertain to global CMC regulations and guidance • Providing regulatory advice to CMC and project teams regarding the applicability/impact on internal programs

Education

• University of New Hampshire

  Bachelor of Arts (B.A.), Justice Studies

  2009 — 2013

• University of New Hampshire

  Bachelor of Science (B.S.), Forensic Science and Technology (Concentration in Biology)

  2009 — 2013