The OpportunityThe Regulatory Affairs team at Entrada is a dynamic, growing team. The Associate Director will support global regulatory activities for Entrada's pipeline, with a focus on clinical-stage assets. Reporting to the Senior Vice President, Regulatory Affairs, the ideal candidate will collaborate with cross-functional teams to efficiently advance the global development of genetic medicines for rare and serious unmet medical needs. This high-impact role will be critical to the success of the Regulatory department and Entrada's mission to discover, develop and commercialize life-changing medicines that are safe, effective and accessible to those who need them.
Responsibilities- Support the global regulatory strategy for multiple clinical stage programs.
- Partner on the development, preparation, and timely completion of health authority submissions, including the authoring, submission, and archiving for IND, CTA, and EU-CTR submissions.
- 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.
- Participate in study team meetings, providing updates and addressing questions.
- Proactively identify opportunities and risks within our Regulatory department and the development programs, and support approaches to mitigate and resolve risks.
The NecessitiesAt 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 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
What We Offer: Meaningful Work, Fair Rewards, and Real SupportAt 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 compensation philosophy, in accordance with certain state requirements in the United States and fostering a fair and open environment at the onset.
But we also know it is more than just pay. 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. We pride ourselves on offering competitive benefits that empower our employees and reflect the value of their contributions - offering paid, gender-inclusive parental leave, holistic support for your health and well-being, education reimbursement, discretionary time off and commuting benefits aligned to your working model. If you find yourself working from our office in Boston's Seaport District, this puts you steps away from some of the best the city has to offer.
"Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. 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."
- Kerry Robert, SVP of People
The salary for this opportunity ranges from $171,000-$204,000. 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
