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Director, Regulatory Affairs

4 months ago

Boston, United States Entrada Therapeutics Full time
The Organization

What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.

Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable. We have also partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready 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 Addition to Our Team

You have a resourceful, collaborative, and versatile approach to work and bring extensive regulatory strategic abilities to interact with executive management and external health authorities. You are someone who thrives in a start-up regulatory function with an ability to identify potential solutions to current and future challenges. You follow up and follow through, efficiently connecting problems with solutions. You work successfully in a team environment and with strong interpersonal skills in order to effectively build working relationships inside and outside of the company.

The Opportunity

The Regulatory Affairs team at Entrada is a dynamic, growing team that develops and executes innovative regulatory strategies to efficiently advance Entrada’s pipeline of intracellular therapeutics for the treatment of devastating diseases. The Director will support global regulatory activities for Entrada’s pipeline, including preclinical and clinical-stage assets. Reporting to the Senior Vice President, Regulatory Affairs, the successful candidate will support the development of comprehensive regulatory strategies and collaborate with cross-functional teams to efficiently develop products in accordance with global regulations and guidelines.

This high-impact role will be critical to the success of the Regulatory department and Entrada’s development teams. The successful candidate will have a demonstrated track record of contributing to innovative regulatory strategies within the biotech or pharmaceutical industry, working collaboratively with cross-functional development teams, and be eager to lead and contribute. A desire to work within a dynamic, fast-paced environment is essential.

Responsibilities

  • Support preclinical and clinical global regulatory strategy development, including considerations for rare diseases in pediatric and adult populations.
  • Proactively identify regulatory opportunities and risks; identify alternative approaches to resolve development program challenges and appropriately mitigate risks.
  • Develop and execute innovative regulatory strategies for rare disease drug development, including obtaining global health authority designations to support expedited pathways.
  • Develop strong working relationships and guide cross-functional project teams to support achievement of portfolio deliverables throughout the product lifecycle.
  • Lead the authoring, review, approval, and submission process for IND and CTA submissions.
  • Build and maintain strong relationships with external stakeholders, including regulatory agencies, CROs, CDMOs, consulting groups, and other third parties.
  • Lead activities establishing a top-tier Regulatory Affairs department, including the development of policies and procedures aligned with GxPs, Guidance, and best practices.
  • Inspire, manage, and lead colleagues and direct reports.
  • Foster a culture of collaboration and excellence.

The Necessities

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

  • Humanity - We genuinely care about patients and about one another.
  • 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.
  • Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

  • Results-oriented individuals with a strong work ethic and demonstrated record of accomplishment, including with IND, CTA, NDA, BLA, and/or MAA submissions.
  • Comprehensive knowledge of the drug development process, global regulations, health authorities, and guidelines, including GxP regulations, ICH, and FDA Guidance.
  • Experience with rare disease, pediatrics, innovative treatments, and the neuromuscular or neurodegenerative therapeutic area is strongly preferred.
  • Excellent organizational skills and ability to work on multiple projects with tight timelines.
  • Excellent verbal and written communication skills, including the ability to present strategic and tactical issues to project teams, management, and regulatory agencies.
  • Strong interpersonal skills and desire to work collaboratively with matrixed project teams.
  • Self-motivated and driven with a proactive work style; an ability to complete complex tasks with minimal supervision is essential.
  • BS or MS with at least 10 years of increasing responsibility in Regulatory Affairs; Advanced degree, RAC, or education in a scientific field strongly preferred.
  • Integrity, ownership mentality, desire to learn and grow, and a commitment to excellence.
The Perks

By becoming a team member here at Entrada, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.

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. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent 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.

Privacy Statement

Entrada Therapeutics, Inc. (the “Entrada,” “we,” “us,” or “our”) respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement here to understand how and when your data is being used.