Entrada Therapeutics

Entrada Therapeutics

Director, Regulatory Writing

Boston, MA · Director

Sponsorship not specified$44k-$601kDetected 51 days ago
GCPProject ManagementFDA RegulatoryAnimal StudiesCommunicationCollaborationMicrosoft OfficeRegulatory Affairs

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odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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About the role

  • The Regulatory Affairs team at Entrada is a dynamic, growing team.

Responsibilities

  • 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.
  • 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.
  • Meaningful Work, Fair Rewards, and Real Support
  • We believe meaningful work deserves meaningful reward, and view compensation as one way to show appreciation for the collaboration, curiosity, and commitment that drive our mission forward.

Requirements

  • You bring energy and enthusiasm to your role, while recognizing that a steady and consistent effort is required to successfully develop novel medicines.

Compensation

  • But we also know it is more than just pay.
  • At Entrada, our approach to compensation is grounded in transparency, equity, and performance, recognizing the unique contributions each person brings.
  • We believe meaningful work deserves meaningful reward, and view compensation as one way to show appreciation for the collaboration, curiosity, and commitment that drive our mission forward.
  • The salary for this opportunity ranges from $220,000 - $249,711.
  • The final base compensation offered will depend on several considerations which include but may not be limited to a candidate's skills, competencies, experience and other job-related factors permitted by law.
  • The final salary offered may fall outside of this range. #LI-GG1 #LI-Remote
  • $220,000 - $249,711 USD

Benefits

  • At Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity.
  • We believe in transparency and equity and are committed to sharing salary ranges for every position, along with insight into our
  • When you join Entrada, you'll be part of a mission-driven team with access to comprehensive health, dental and vision coverage
  • life and disability insurance
  • At Entrada, our approach to compensation is grounded in transparency, equity, and performance, recognizing the unique contributions each person brings.

Company info

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

Equal opportunity

  • Entrada Therapeutics is an equal opportunity employer.
  • Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.
  • Third Party Staffing Agencies
  • Entrada does not accept unsolicited resumes from any source other than directly from candidates.

Visa & Work Authorization

  • rientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law
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This listing is sourced directly from Entrada Therapeutics's careers page and normalized into a canonical job model.