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Associate Director, Regulatory Affairs

Employer
Entrada Therapeutics
Location
Boston, MA
Start date
Apr 14, 2024

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown

Job Details

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.

The Opportunity

You 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 ideal candidate will have a demonstrated track record of contributing to innovative regulatory strategies within the biotech or pharmaceutical industry and will be working collaboratively with cross-functional development teams.

Responsibilities
  • Support preclinical and clinical global regulatory strategy development, including considerations for rare diseases in pediatric and adult populations.
  • Develop strong working relationships with Regulatory colleagues and cross-functional project teams to support efficient execution, including 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 Discovery, Nonclinical, Quality, Manufacturing, and Clinical to ensure alignment with regulatory requirements throughout the product lifecycle.
  • Ensure clinical trials and operations are compliant with applicable FDA, ICH, EMA, and industry standards.
  • Proactively identify regulatory opportunities and risks; identify alternative approaches to resolve development program challenges and appropriately mitigate risks.
  • Support the development, preparation, and timely completion of health authority submissions, including leading the authoring, review, and approval process for IND and CTA submissions.
  • Stay abreast of regulatory requirements, trends, and changes, informing senior leadership as necessary.
  • Contribute to the development of policies and procedures aligned with GxPs, Guidance, and corporate objectives.
  • 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:

  • BS or MS with at least 5 years of increasing responsibility in Regulatory Affairs; Advanced degree, RAC, or education in a scientific field preferred.
  • 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 diseases, pediatrics, innovative treatments, and the neuromuscular or neurodegenerative therapeutic area is a plus.
  • 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 and ability to follow through on assignments.
  • 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.

Company

Entrada Therapeutics is a biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines, Endosomal Escape Vehicle (EEV™) therapeutics, to engage intracellular targets that have long been considered inaccessible and undruggable. The Company’s EEV therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues with an improved therapeutic index. Through its proprietary, highly versatile and modular EEV platform, Entrada is building a robust development portfolio of oligonucleotide-, antibody- and enzyme-based programs for the potential treatment of neuromuscular diseases, immunology, oncology and diseases of the central nervous system. The Company’s lead oligonucleotide programs include ENTR-601-44 targeting Duchenne muscular dystrophy (DMD) and ENTR-701 targeting myotonic dystrophy type 1 (DM1).

Stock Symbol: TRDA
Stock Exchange: NASDAQ

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Company info
Website
Phone
+1-857-520-9158
Location
One Design Center Place Suite 17- 500
Boston
Massachusetts
02210
US

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