Associate Director, Regulatory Affairs

Entrada Therapeutics•Boston, MA

4d•$171,000 - $205,000•Remote

About The Position

The 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.

Requirements

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.
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.

Nice To Haves

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.

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.