Associate Director/Director of Regulatory Affairs

Piper Companies is seeking an Associate Director/Director, Regulatory Strategy to join an innovative organization reputed company the gene therapy and biotechnology space for a fully remote, East Coast–reputed company contract-to-hire opportunity. The Associate Director/Director, Regulatory Strategy will play a critical role in shaping early development regulatory plans, supporting Pre-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 Strategy include

• reputed company and execute early-phase regulatory strategies for gene therapy programs, with emphasis on Pre-IND, INTERACT, and IND milestones.
• Translate nonclinical animal study designs, toxicology results, and dosing rationales into clear, 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 align on development plans.
• Prepare for and actively participate in FDA interactions, contributing to question strategy, meeting preparation, and post-meeting follow-up. Qualifications for the Associate Director/Director, Regulatory Strategy include
• Master’s degree or higher in a life sciences discipline; PhD strongly preferred.
• Direct hands-on regulatory experience in gene therapy (cell therapy experience may be considered).
• Demonstrated involvement in Pre-IND activities and early IND-enabling work.
• Proven ability to independently produce high-quality 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, sick 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 strategy, 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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