Associate Director/Director of Regulatory Affairs
Piper Companies is seeking an Associate Director/Director of Regulatory Affairs to join an early-stage biotechnology organization focused on advanced gene therapy development for a remote contract position. The Associate Director/Director of Regulatory Affairs will play a key role in shaping regulatory strategy and supporting global filings for rare disease programs in a fast-moving development environment. Responsibilities of the Associate Director/Director of Regulatory Affairs include:
- Support the development and execution of global regulatory strategies from preclinical through early clinical stages.
- Lead preparation and maintenance of regulatory submissions including INDs, CTAs, and related amendments.
- Contribute to regulatory briefing materials and actively support interactions with FDA and EU health authorities.
- Partner cross-functionally with clinical, nonclinical, quality, and CMC teams to ensure regulatory alignment.
- Assess regulatory risk and provide practical guidance to maintain development timelines.
Qualifications for the Associate Director/Director of Regulatory Affairs include:
- PhD, PharmD, MD, or MS in life sciences, molecular biology, pharmacology, or a related discipline.
- 7–10 years of regulatory affairs experience within biotechnology or pharmaceutical development.
- Hands-on experience supporting INDs, CTAs, and early-phase clinical programs.
- Working knowledge of biologics and gene therapy regulatory pathways, including nonclinical requirements.
- Strong regulatory writing skills with the ability to communicate effectively across functions.
Compensation for the Associate Director/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 4/8/26. 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