Entrada Therapeutics

Entrada Therapeutics

Associate Director, Regulatory Affairs

Boston, MA · Director

Sponsorship not specified$44k-$601kDetected 8 days ago
FDA RegulatoryCommunicationCollaborationOrganizational SkillsGxPRegulatory Affairs

About the role

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

Responsibilities

  • Support the global regulatory strategy for multiple clinical stage programs.
  • Develop 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 groups, and other third parties.
  • Collaborate with various departments including Nonclinical, Quality, Manufacturing, and Clinical to maximize opportunities while ensuring alignment with regulatory requirements.
  • Lead or contribute to the development and review of procedures and work instructions aligned with GxPs, Guidance, industry standards, and corporate objectives.
  • Proactively identify opportunities and risks within our Regulatory department and the development programs, and support approaches to mitigate and resolve risks.
  • Meaningful Work, Fair Rewards, and Real Support
  • At Entrada, we know that meaningful work deserves meaningful reward - and we view compensation as one way we 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

  • The salary for this opportunity ranges from $171,000-$204,000.

Benefits

  • At Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity.
  • 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; with a 401(k) match.
  • "Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings.

Company info

  • 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, GxP regulations, ICH, and FDA Guidance.
  • Experience with rare diseases, pediatrics, genetic medicines, or leveraging expedited development pathways (eg, accelerated approval) is strongly preferred; experience with neuromuscular or ocular therapeutic areas is a plus.
  • A strong work ethic, excellent verbal and written communication skills, and a desire to work collaboratively with matrixed project teams.
  • Excellent organizational 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.
  • This is a US based remote position, with preference given to local New England based candidates. This role will require minimum quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA
  • 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.