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 Associate Director/Director, Regulatory Strategy (commensurate with experience) to join our growing Regulatory Science team. As a Regulatory Science team member, they will work with the FDA and EMA, as well as national regulatory authorities globally to find innovative ways to collaborate.
We seek an experienced regulatory strategist who will provide robust and creative regulatory strategies to support the expedited and efficient development of Omega’s innovative DNA-sequence-targeting, mRNA-encoded products. You will be responsible for the preparation, submission, and approval of INDs, CTAs, orphan drug designations, and managing corresponding interactions with regulatory authorities.
- Understanding and interpreting complex scientific issues as they relate to regulatory requirements and strategy for assigned projects, and provide knowledge and expertise to guide the team on appropriate regulatory strategies
- Manage preparation and submission of high-quality dossiers including development of timelines
- Collaborate with regulatory-CMC, regulatory operations, and other functions to ensure seamless integration of various components into submissions as well as high quality submissions
- Lead transparent and proactive interactions with regulatory agencies globally
- Drive adherence to regulatory guidelines for development of gene therapy products
- Maintains knowledge of relevant evolving regulation and guidance; review draft regulatory guidelines and monitor trends
- Knowledgeable in ICH, FDA and EMA guidelines
- Experience in oncology or rare disease is preferred
- Understanding of advanced therapy products development
- Ability to work effectively in a collaborative, team environment
- Independently motivated, detail oriented, and good problem-solving ability
- Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
- Excellent communications skills and ability to influence across multiple functions
- BA/BS degree in life sciences, MS/PhD preferred
- Relevant experience in the Biotech/Pharmaceutical Industry, including 5-7 years within Regulatory Affairs
- Experience leading Agency meetings and IND and/or CTA activities