Director, Regulatory Affairs CMC

Scorpion Therapeutics; United States; Hybrid; USD 250,000 - 350,000; Full time

Job summary

Scorpion Therapeutics is seeking a Director of Regulatory Affairs CMC focused on gene therapy for CNS rare diseases. You will support development and commercialization strategies, lead global regulatory plans, and drive IND/BLAs/MAA submissions with health authorities.

The role requires deep CMC regulatory expertise, 10+ years in regulatory affairs, and a track record in biologics or gene therapy. Remote-friendly with some travel.

Qualifications

• Bachelor's degree in life sciences is required.
• 10+ years in Regulatory Affairs CMC with emphasis on gene therapy, viral vectors, or biologics.
• Experience with BLA regulatory processes and submissions.
• Proven track record leading global submissions for advanced therapies.
• Solid understanding of biologics manufacturing, characterization and analytical development.

Responsibilities

• Provide CMC regulatory input across cross-functional teams.
• Lead global regulatory plans and submission strategies.
• Support INDs, BLAs, and MAAs with tactical execution.
• Facilitate interactions with health authorities.
• Ensure compliance with evolving gene therapy and biologics regulations.

Skills

Regulatory Affairs CMC

Gene therapy

Viral vectors

Biologics manufacturing

Global submissions

Health authority interactions

INDs/BLAs/MAAs

Regulatory strategy

Education

Bachelor's degree in life sciences

Job description

Role

Director of Regulatory Affairs CMC focusing on gene therapy for rare CNS diseases, supporting development and commercialization strategies.

Responsibilities

• provide CMC regulatory input across teams
• lead global regulatory plans
• contribute to submission strategies (INDs, BLAs, MAAs)
• support health authority interactions
• ensure compliance with evolving regulations in gene therapy and biologics

Requirements

• Bachelor's in life sciences
• 10+ years in Regulatory Affairs CMC, with 5+ years specializing in gene therapy, viral vectors, or biologics
• BLA experience
• proven record of leading global submissions for advanced therapies
• solid understanding of biologics manufacturing, characterization, and analytical development

Preferred

• advanced degree in Molecular Biology, Biochemistry, or Pharmaceutical Sciences

HighValue

• extensive experience with biologics and gene therapy regulations (FDA CBER, EMA ATMP, ICH Q-series)
• viral vector technologies (AAV, lentivirus)
• global health authority interactions

Work Setup

based in New York, Houston, or remote; travel to Houston required.