Associate Director/Director, CMC Regulatory Affairs

Piper Companies is seeking an Associate Director/Director, Regulatory Affairs (CMC) to support a clinical‑stage biotechnology organization in the gene therapy space for a contract‑to‑hire position based in the United States (EST‑friendly). The Associate Director/Director, Regulatory Affairs (CMC) will serve as a hands‑on CMC regulatory expert, supporting late‑stage gene therapy programs already in the clinic and driving preparation toward future BLA submissions.

Responsibilities of the Associate Director/Director, Regulatory Affairs (CMC) include:

· Develop and execute CMC regulatory strategy for viral vector gene therapy programs progressing from clinical development toward approval.

· Author and review detailed CMC sections for INDs, amendments, and BLAs, with direct ownership of technical content rather than oversight alone.

· Act as the primary CMC regulatory subject matter expert, advising on viral vector manufacturing, analytical characterization, comparability, and process changes.

· Partner closely with CMC, manufacturing, and technical teams to assess regulatory risk and resolve issues related to manufacturing changes or scale‑up.

· Lead and influence cross‑functional stakeholders and technical contributors while maintaining regulatory alignment and decision accountability.

Qualifications for the Associate Director/Director, Regulatory Affairs (CMC) include:

· Direct, hands‑on experience preparing CMC sections of a gene therapy BLA, with demonstrated technical depth.

· Strong background in viral vector gene therapies, such as AAV or lentiviral platforms, within late‑stage clinical programs.

· Experience supporting US BLA submissions, with additional exposure to Canadian and/or European regulatory pathways preferred.

· Proven ability to manage complex CMC regulatory questions and interact directly with health authorities on technical topics.

· Bachelor’s degree in a scientific discipline or equivalent experience; advanced degrees are welcome but not required.

Compensation for the Associate Director/Director, CMC 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: CMC regulatory affairs, gene therapy, viral vectors, AAV, lentiviral, biologics, IND, CTA, IMPD, analytical development, process development, manufacturing changes, comparability, FDA, EMA, regulatory submissions, ATMP, lifecycle management, startup biotech, cross-functional collaboration, regulatory writing, global regulations.

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