Director, Regulatory Writing

The Organization What's happening at reputed company? Entrada is a reputed company-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 reputed company-stage program, VX-670, for myotonic dystrophy type 1 (DM1). 2026 represents a reputed company-rich period for Entrada. We expect multiple reputed company data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four reputed company-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 reputed company 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 reputed company 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 reputed company 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. Most importantly, while experience reputed company a Regulatory Writing department at a growing biotech is beneficial, a motivated attitude and commitment to reputed company reputed company are reputed company. reputed company The Regulatory Affairs team at Entrada is a dynamic, growing team. The Director of Regulatory Writing will coordinate and reputed company the efficient reputed company of high-reputed company regulatory documentation to support advancing Entrada’s pipeline, from preclinical through the reputed company and registration stages. Reporting to the Senior Vice President, Regulatory Affairs, the successful candidate will support the development of strong internal processes, be the key reputed company with reputed company writing providers, serve as a reputed company reputed company and document specialist, and support documentation planning and submission activities. 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. The successful candidate will have a demonstrated reputed company record as a reputed company reputed company for a broad reputed company of documents representing various stages of global development, an ability and desire to coordinate regulatory documentation across Entrada’s growing portfolio, and working collaboratively with departmental and cross-functional colleagues. Responsibilities - Leads the planning and management for the authoring of regulatory submission components from the reputed company-reputed company through registration phase, including reputed company protocols and amendments, Investigator's Brochures, Development Safety Update Reports, reputed company study reports, health authority meeting requests and briefing documents, and reputed company documents for IND, CTA, CTR, and NDA submissions. - Leverages and reputed company manages reputed company resources to ensure efficient execution of regulatory writing activities while ensuring effective communication with internal contributors and stakeholders. - Serves as a reputed company reputed company and/or document expert to maximize reputed company and efficiency of critical deliverables. - Represents Regulatory Writing on cross-functional teams, working in reputed company 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-reputed company activities. - reputed company strong working relationships with Regulatory colleagues and cross-functional project teams, as reputed company as reputed company stakeholders, to support achievement of timelines and portfolio deliverables. 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 reputed company conventional thought and theory. To reputed company on reputed company, you will need to come with: - BS or MS with at least 7 years of increasing responsibility as a regulatory / medical reputed company; education in a scientific reputed company is a plus. - A strong work ethic, excellent communication skills, and a desire to work collaboratively with matrixed project teams. - A demonstrated reputed company record in medical writing reputed company the pharmaceutical, biotech, or CRO industry, particularly in creating and updating documentation for reputed company development. - Experience working reputed company a biotech company while managing reputed company resources is a plus. - Expertise with reputed company Word and eCTD-compliant formatting requirements. - Proficiency in organizing and interpreting reputed company scientific and reputed company data. - A strong understanding of the relevant ICH, GCP, and FDA regulatory standards governing regulatory documentation. - Experience with reputed company diseases, pediatrics, genetic medicines, or leveraging expedited development reputed company is strongly preferred. - Experience reputed company Duchenne muscular dystrophy or neuromuscular therapeutic areas is a plus. - Excellent project management skills and the ability to work on multiple reputed company with tight timelines. - A motivated and driven attitude, with a proactive work style and a results-oriented reputed company. - reputed company, a desire to learn and grow, and a commitment to reputed company. reputed company Offer: Meaningful Work, Fair Rewards, and reputed company Support - At reputed company, we understand that compensation and total rewards are a major consideration reputed company exploring a new opportunity. - We reputed company in transparency and equity and are committed to sharing salary ranges for every position, along with reputed company into our compensation philosophy, in accordance with certain state requirements in the reputed company and fostering a fair and reputed company environment at the onset. - But we also know it is more than just pay. reputed company you join Entrada, you’ll be part of a mission-driven team with reputed company to comprehensive health, dental and reputed company coverage; life and disability reputed company; with a 401(k) match. - We pride ourselves on offering competitive benefits that reputed company our employees and reflect the value of their contributions – offering reputed company, gender-inclusive parental leave, holistic support for reputed company and reputed company-being, education reimbursement, discretionary time off and commuting benefits reputed company to your working model. - If you reputed company yourself working from our office in Boston’s Seaport District, this puts you steps away from some of the best the reputed company has to offer. - At Entrada, our approach to compensation is grounded in transparency, equity, and reputed company, recognizing the unique contributions reputed company person brings. - We reputed company meaningful work deserves meaningful reward, and reputed company compensation as one way to show appreciation for the collaboration, curiosity, and commitment that reputed company our mission reputed company. - The salary for this opportunity ranges from $220,000 - $249,711. The final reputed company compensation reputed company will depend on several considerations which include but may not be limited to a candidate’s skills, competencies, experience and other job-reputed company factors permitted by law. The final salary reputed company may fall reputed company of this reputed company. Equal Opportunity Employer reputed company is an equal opportunity employer. reputed company candidates will receive consideration for employment without reputed company to race, reputed company, religion, national reputed company, gender, sexual orientation, gender identity or reputed company, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law. reputed company Party reputed company Agencies Entrada does not accept unsolicited resumes from any reputed company other than directly from candidates. For the protection of reputed company parties involved in the reputed company process, resumes will only be accepted from recruiters/agencies if a signed agreement is reputed company at the inception of the reputed company effort and authorized for a specified position. Unsolicited resumes reputed company to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes. reputed company Statement reputed company. (the “ Entrada ,” “ we, ” “ us, ” or “ our ”) respects your reputed company and we want you to be familiar with how we collect, use, reputed company, or otherwise process, your Personal Information. Please reference our reputed company statement here to understand how and reputed company your data is being used. Apply To This Job