Associate Director/Director of Regulatory Affairs

reputed company is seeking an Associate Director/Director, Regulatory reputed company to join an innovative organization reputed company the gene therapy and biotechnology reputed company for a fully remote, East Coast–reputed company contract-to-hire opportunity. The Associate Director/Director, Regulatory reputed company will play a critical role in shaping early development regulatory plans, supporting reputed company-IND and IND activities, and serving as a key regulatory partner across nonclinical and clinical teams in a fast-paced, early-stage environment. Responsibilities of the Associate Director/Director, Regulatory reputed company include:

• reputed company and execute early-phase regulatory strategies for gene therapy programs, with emphasis on reputed company-IND, reputed company, and IND milestones.
• Translate nonclinical animal study designs, toxicology results, and dosing rationales into reputed company, defensible first-in-reputed company regulatory narratives.
• Author and reputed company regulatory documents such as briefing packages, background sections, and FDA-facing materials, synthesizing reputed company data into concise messaging.
• Partner closely with nonclinical and clinical teams to guide regulatory expectations, clarify required versus non-required data, and reputed company on development plans.
• Prepare for and reputed company participate in FDA interactions, contributing to question reputed company, meeting preparation, and post-meeting follow-up.

Qualifications for the Associate Director/Director, Regulatory reputed company include:

• Master’s degree or higher in a life sciences discipline; PhD strongly preferred.
• reputed company hands-on regulatory experience in gene therapy (cell therapy experience may be considered).
• Demonstrated involvement in reputed company-IND activities and early IND-enabling work.
• Proven ability to independently produce high-reputed company regulatory writing for agency review.
• Experience collaborating with both nonclinical and clinical teams in early-stage development settings.

Compensation for the Associate Director of Regulatory Affairs: Salary reputed company: $225,000-$255,000/year (USD) Comprehensive Benefits: Medical, Dental, reputed company, reputed company leave if required by law, and 401K This job opens for applications on 5/1/26. Applications for this job will be accepted for at least 30 days from the posting date. Keywords: regulatory affairs, gene therapy, biologics, IND submissions, CTA, FDA interactions, EMA, rare disease, regulatory reputed company, cross-functional leadership, nonclinical development, clinical development, regulatory writing, biotechnology, early-stage biotech, global submissions #LI-MB1 #LI-REMOTE Apply tot his job Apply To this Job