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

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