Senior CMC Regulatory Lead — Submissions (Remote)

Scorpion Therapeutics; Boston (MA); On-site; USD 175,000 - 200,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

Company-paid life/AD&D/disability

401(k) match up to 6%

Long-term stock incentives

ESPP

Discretionary quarterly bonus

Flexible wellness benefit

Generous PTO & paid holidays

Job summary

Scorpion Therapeutics is seeking a senior Regulatory CMC leader to plan, prepare, and execute regulatory activities for small molecule and ASO programs, partnering with cross-functional teams and external vendors.

The role focuses on IND/IMPD/NDA/BLA submissions, health authority interactions, lifecycle management, and post-approval changes, with a strong emphasis on data integrity and compliance.

Qualifications

• 10+ years of progressive Regulatory CMC experience.
• Experience preparing/reviewing IND/IMPD/NDA/BLA submissions.
• Strong FDA and global CMC regulatory knowledge.
• ASO/oligonucleotide therapy experience preferred.
• Leadership in complex CMC regulatory activities.

Responsibilities

• Support development and execution of CMC regulatory strategies.
• Author, compile, and review CMC sections for submissions.
• Coordinate CMC content with Quality, Analytical, Development, and Manufacturing.
• Support health authority interactions and information requests.
• Maintain CMC regulatory compliance for clinical and commercial supply.
• Assist with post-approval changes, comparability, transfers.
• Manage external consultants, CMOs, CROs, regulatory vendors.

Skills

Regulatory CMC leadership

FDA/global CMC knowledge

IND/IMPD/NDA/BLA submissions

ASO/oligonucleotide experience

Cross-functional leadership

Project management

Communication skills

AI/digital document tools

Education

BS/MS/PhD in Chemistry/Pharmaceutical Sciences/Chemical Engineering/Biochemistry

Tools

AI/digital tools

Job description

Scorpion Therapeutics is seeking a senior Regulatory CMC leader to plan, prepare, and execute regulatory activities for small molecule and ASO programs, partnering with cross-functional teams and external vendors.

The role focuses on IND/IMPD/NDA/BLA submissions, health authority interactions, lifecycle management, and post-approval changes, with a strong emphasis on data integrity and compliance.