Director, Regulatory Writing

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 (VX-670).

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.

You are passionate and dedicated to your work, with a commitment to overcome challenges and deliver on our potential to develop transformative therapies for patients and their caregivers. You bring energy and enthusiasm to your role, while recognizing that a steady and consistent effort is required to successfully develop novel medicines. Most importantly, while experience within a Regulatory Writing department at a growing biotech is beneficial, a motivated attitude and commitment to collective success are paramount.

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
• Creativity - We are creative problem solvers.
• Collaboration - We are more than the sum of our parts.
• Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

• 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.
• A demonstrated track record in medical writing within the pharmaceutical, biotech, or CRO industry, particularly in creating and updating documentation for clinical development. Experience working within a biotech company while managing external resources is a plus.
• 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.
• Experience with rare diseases, pediatrics, genetic medicines, or leveraging expedited development pathways is strongly preferred. Experience within Duchenne muscular dystrophy or neuromuscular therapeutic areas is a plus.
• Excellent project management skills and the ability to work on multiple projects with tight timelines.
• A motivated and driven attitude, with a proactive work style and a results-oriented mindset.
• Integrity, a desire to learn and grow, and a commitment to excellence.