Associate Director/Director of Regulatory Affairs
Piper Companies is seeking an Associate Director/Director, Regulatory Strategy to join an innovative organization within the gene therapy and biotechnology space for a fully remote, East Coast–aligned 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:
• Develop 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-human regulatory narratives.
• Author and lead regulatory documents such as briefing packages, background sections, and FDA-facing materials, synthesizing complex 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 Range: $225,000-$255,000/year (USD)
Comprehensive Benefits: Medical, Dental, Vision, 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
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Responsibilities of the Associate Director/Director, Regulatory Strategy include:
• Develop 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-human regulatory narratives.
• Author and lead regulatory documents such as briefing packages, background sections, and FDA-facing materials, synthesizing complex 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 Range: $225,000-$255,000/year (USD)
Comprehensive Benefits: Medical, Dental, Vision, 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