Backed by GV.
About the role
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor's degree in life sciences, regulatory affairs, or a related field
- 7+ years of experience in regulatory affairs or regulatory operations within the pharmaceutical or biotechnology industry
- Demonstrated experience managing IND/CTA and BLA/MAA submissions from planning through filing
- Strong working knowledge of eCTD structure, regulatory publishing tools, and document management systems (e.g., Veeva Vault RIM or similar)
- Proven project management skills, with the ability to manage multiple concurrent programs and competing priorities
- Excellent written and verbal communication skills, with strong cross-functional collaboration and stakeholder management abilities
More about this role
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.
Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit www.primemedicine.com .
The Senior Manager,...
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