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.