Director, Regulatory Writing

Role: Director of Regulatory Writing at Entrada Therapeutics, leading the development of high-quality regulatory documentation to support clinical and registration phases of gene and oligonucleotide therapies for neuromuscular and inherited retinal diseases, including Duchenne muscular dystrophy and myotonic dystrophy. Responsibilities: plan and manage authoring of clinical protocols, safety reports, study reports, and submissions (IND, CTA, NDA); coordinate external resources; serve as a lead author and document expert; support process improvements and cross-functional collaboration including Regulatory Affairs, Program Management, and external stakeholders. Requirements: BS/MS with 7+ years in regulatory/medical writing within biotech, pharma, or CRO sectors; strong knowledge of ICH, GCP, FDA standards; proficiency in Microsoft Word and eCTD formatting; experience with rare diseases, genetic medicines, or expedited development pathways preferred. HighValue: gene and oligonucleotide therapies, neuromuscular and retinal diseases, late-stage clinical development, global regulatory submissions, cross-functional collaboration. WorkSetup: on-site in Boston, with a focus on leadership in a growing, mission-driven team.