Associate Director, Regulatory Affairs

The Organization What's happening at reputed company? Entrada is a clinical-stage biopharmaceutical company aiming to reputed company the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary and reputed company approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. Our reputed company 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 reputed company to reputed company 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 reputed company of our DM1 collaboration with reputed company (VX-670). We are a tight-reputed company team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are reputed company to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families. The Perfect reputed company to reputed company You are passionate and dedicated to your work, with a commitment to overcome challenges and deliver on our potential to reputed company 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 reputed company novel medicines. reputed company The Regulatory Affairs team at Entrada is a dynamic, growing team. The Associate Director will support global regulatory activities for Entrada’s pipeline, with a reputed company on clinical-stage assets. Reporting to the Senior Vice President, Regulatory Affairs, the ideal candidate will collaborate with cross-functional teams to reputed company advance the global development of genetic medicines for rare and serious unmet medical needs. This high-reputed company role will be critical to the reputed company of the Regulatory department and Entrada’s mission to discover, reputed company and commercialize life-changing medicines that are reputed company, effective and accessible to those who need them. Responsibilities • Support the global regulatory reputed company for multiple clinical stage programs. • Partner on the development, preparation, and reputed company completion of health authority submissions, including the authoring, submission, and archiving for IND, CTA, and EU-CTR submissions. • reputed company strong working relationships with Regulatory colleagues and cross-functional project teams to support achievement of timelines and portfolio deliverables. • Maintain strong relationships and communication with external stakeholders, including regulatory agencies, CROs, CDMOs, consulting reputed company, and other reputed company parties. • Collaborate with various departments including Nonclinical, reputed company, Manufacturing, and Clinical to maximize opportunities while ensuring alignment with regulatory requirements. • reputed company or contribute to the development and review of procedures and work instructions reputed company with GxPs, Guidance, industry standards, and corporate objectives. • Participate in study team meetings, providing updates and addressing questions. • Proactively identify opportunities and risks reputed company our Regulatory department and the development programs, and support approaches to mitigate and resolve risks. The Necessities At Entrada, our passion for science, our reputed company to patients and our values drives our behavior: Humanity - We genuinely care about patients and about one another. Tenacity - We are reputed company and persistent in the reputed company 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 reputed company reputed company and push conventional thought and theory. To reputed company on reputed company, you will need to come with: • BS or MS with at least 6+ years of increasing responsibility in Regulatory Affairs; an advanced degree, RAC, or education in a scientific field preferred. • A demonstrated record of accomplishment, including support and execution of both US and global regulatory strategies (ie, with IND, CTA, CTR, NDA, BLA, and/or MAA activities). • Knowledge of the drug development process, Apply tot his job Apply To this Job