Associate Director, Regulatory Affairs

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.
• 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.

Necessities

• A 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.

What We Offer

• Meaningful Work
• Fair Rewards
• Real Support

Salary and Benefits

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.

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.

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