About Omega Therapeutics:
Omega Therapeutics is a development-stage biotechnology company pioneering a new class of programmable, mRNA-encoded therapeutics to transform human medicine. The OMEGA Epigenomic Programming™ platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth and differentiation to cell death. The OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega’s engineered, modular, and programmable mRNA-encoded epigenetic medicines, Omega Epigenomic Controllers™, target specific intervention points amongst the thousands of validated novel DNA-sequence-based epigenomic targets we have mapped to tune single or multiple genes to treat and cure disease through Precision Genomic Control™. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.
About the Role:
Omega Therapeutics, Inc. is seeking an experienced Associate Director/Director, Regulatory CMC to join our growing Regulatory Science team.
They will be responsible for developing innovative global regulatory CMC strategy and lead preparation of CMC and Quality related health authority agency correspondence and regulatory applications. This is an exciting role for a qualified and motivated individual to manage regulatory CMC activities over several products for the company.
- Provide regulatory CMC strategic leadership within regulatory science and on cross-functional teams to support development of a new class of DNA-sequence-targeting, mRNA-encoded therapeutics
- Develop and proactively communicate regulatory CMC strategies, risks, and key issues in an evolving regulatory landscape
- Act as the regulatory CMC lead and department representative in matrixed teams for development programs
- Support development of manufacturing, analytical, and supply chain strategies and provide expert regulatory guidance to enable global implementation
- Define CMC content (data and documentation) requirements for quality sections of regulatory dossiers (IND/CTA/MF and BLA/MAA)
- Plan and manage activities for the preparation of high-quality, CMC-related global regulatory submissions in accordance with program timelines
- Evaluation of CMC-related change proposals for regulatory impact and filing requirements; provide strategic regulatory guidance for optimal implementation of changes
- Lead and support global health authority interactions for CMC-related topics including defining strategy, preparation, and meeting facilitation
- Comprehensive knowledge of regulatory guidelines; with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products
- Experience with biologic products preferred
- Ability to develop/maintain strong working relationships, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently
- Ability to interact with CMC technical experts regarding process development and analytical issues
- Ability to identify trends and changes in regulations affecting the regulatory landscape and recommend changes in internal business processes, where necessary
- BA/BS degree in a scientific/engineering discipline, MS/PhD preferred
- 5+ years’ experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) as a strong dossier preparation contributor for IND/CTA/MF and BLA/MAA submissions