Backed by 5AM Ventures.
About the role
The Regulatory Affairs team at Entrada is a dynamic, growing team. The Director of Regulatory Writing will coordinate and lead the efficient generation of high-quality regulatory documentation to support advancing Entrada’s pipeline, from preclinical through the clinical and registration stages. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- BS or MS with at least 7 years of increasing responsibility as a regulatory / medical writer, education in a scientific field is a plus
- A strong work ethic, excellent communication skills, and a desire to work collaboratively with matrixed project teams
- Expertise with Microsoft Word and eCTD-compliant formatting requirements
- Proficiency in organizing and interpreting complex scientific and clinical data
- A strong understanding of the relevant ICH, GCP, and FDA regulatory standards governing regulatory documentation
- Excellent project management skills and the ability to work on multiple projects with tight timelines
More about this role
What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary and versatile approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy (DMD) who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered with Vertex Pharmaceuticals to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1 (DM1).
2026 represents a catalyst-rich period for Entrada. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51). These programs are complemented by the ongoing clinical progress of our DM1 collaboration with Vertex...
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