Associate Director, Regulatory Affairs

TL;DR

Associate Director, Regulatory Affairs: Support global regulatory activities for Entrada’s clinical-stage genetic medicine pipeline with an accent on IND/CTA/EU-CTR submissions and cross-functional execution across rare disease programs. Focus on building regulatory strategy, authoring and archiving health authority submissions, and proactively managing regulatory risks and timelines.

Location: US based remote position with preference for New England based candidates; requires minimum quarterly travel to hirify.global Headquarters in Boston, MA

Salary: $171,000–$204,000

Company

hirify.global is a clinical-stage biopharmaceutical company developing genetic medicines for rare neuromuscular and inherited retinal diseases.

What you will do

• Support global regulatory strategy for multiple clinical-stage programs.
• Develop, prepare, and ensure timely completion of health authority submissions, including authoring, submission, and archiving for IND, CTA, and EU-CTR.
• Partner with cross-functional teams to meet timelines and portfolio deliverables.
• Manage relationships and communication with external stakeholders (regulatory agencies, CROs, CDMOs, and consulting groups).
• Collaborate with Nonclinical, Quality, Manufacturing, and Clinical to align regulatory requirements with development execution.
• Lead or contribute to GxP-aligned procedures and work instructions; participate in study team meetings and address questions.

Requirements

• BS or MS with 6+ years of increasing responsibility in Regulatory Affairs; advanced degree, RAC, or scientific education preferred.
• Proven experience supporting and executing US and global regulatory strategies (e.g., IND, CTA, CTR, NDA, BLA, and/or MAA).
• Knowledge of drug development process, GxP regulations, ICH, and FDA Guidance.
• Strong communication and organizational skills; ability to manage multiple projects with tight timelines.
• Experience with rare diseases, pediatrics, genetic medicines, or expedited development pathways (e.g., accelerated approval) is strongly preferred.
• US based remote work with quarterly travel to Boston, MA.

Culture & Benefits

• Comprehensive health, dental, and vision coverage; life and disability insurance.
• 401(k) match.
• Paid, gender-inclusive parental leave; education reimbursement; discretionary time off; commuting benefits aligned to the working model.
• Education reimbursement and holistic support for health and well-being.
• Compensation transparency with salary range disclosure.