Director, Regulatory Writing

Entrada Therapeutics•Boston, MA

9d•Remote

About The Position

Entrada Therapeutics is a clinical-stage biopharmaceutical company focused on developing a new class of medicines for intracellular targets. The company is advancing a portfolio of genetic medicines for neuromuscular and inherited retinal diseases, with lead oligonucleotide programs for Duchenne muscular dystrophy (DMD) and a collaboration with Vertex Pharmaceuticals for myotonic dystrophy type 1 (DM1). Entrada anticipates significant milestones in 2026 with multiple clinical data readouts and four clinical-stage programs in its DMD franchise. The company seeks motivated individuals to join its high-energy, dedicated team committed to improving patient lives. The Director of Regulatory Writing will be a key member of the dynamic Regulatory Affairs team, responsible for leading the efficient generation of high-quality regulatory documentation to support the advancement of Entrada’s pipeline from preclinical through registration stages. This role reports to the Senior Vice President, Regulatory Affairs and involves supporting internal process development, managing external writing providers, serving as a lead author and document specialist, and contributing to documentation planning and submission activities. This position is critical to the success of the Regulatory department and Entrada's mission.

Requirements

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.
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.
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.

Nice To Haves

Experience working within a biotech company while managing external resources is a plus.
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.

Responsibilities

Leads the planning and management for the authoring of regulatory submission components from the pre-clinical through registration phase, including clinical protocols and amendments, Investigator's Brochures, Development Safety Update Reports, clinical study reports, health authority meeting requests and briefing documents, and summary documents for IND, CTA, CTR, and NDA submissions.
Leverages and efficiently manages external resources to ensure efficient execution of regulatory writing activities while ensuring effective communication with internal contributors and stakeholders.
Serves as a lead author and/or document expert to maximize quality and efficiency of critical deliverables.
Represents Regulatory Writing on cross-functional teams, working in close partnership with subject matter experts, Regulatory Affairs, and Program Management.
Expands processes and standards that are critical to Regulatory Writing, including development, maintenance, and improvement of SOPs, authoring guides, and project management tools.
Collaborates with Regulatory Affairs team to support submission-related activities.
Develop strong working relationships with Regulatory colleagues and cross-functional project teams, as well as external stakeholders, to support achievement of timelines and portfolio deliverables.