Senior Associate, Regulatory CMC

Scorpion Therapeutics; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Associate, Regulatory CMC to lead strategy, compliance, and submissions for biologics and cell therapy products. You will prepare IND/IMPD submissions, manage regulatory systems, and support FDA inspections while ensuring 21 CFR Part 1271 compliance.

This role collaborates with Quality, Manufacturing, and R&D teams in a fully remote setup. Applicants should have 5+ years in biotech/pharmaceutical regulatory affairs with CMC submissions experience in

Qualifications

• minimum 5 years in biotech/pharmaceutical industry, with 1-2 years in Regulatory Affairs preferred
• proven experience in CMC submissions for biologics, cell therapies, and device combinations
• strong knowledge of ICH GxP, product lifecycle management, and international regulatory standards

Responsibilities

• prepare/review regulatory documents (IND, IMPD, BLA, MAA)
• manage regulatory systems
• develop long-term CMC strategies
• support FDA and international inspections
• ensure compliance with 21 CFR Part 1271 and global regulations
• collaborate with Quality, Manufacturing, and R&D teams

Job description

Role

Senior Associate, Regulatory CMC supporting biopharma biologics and cell therapy products, with focus on strategy, compliance, and submissions.

Responsibilities

• prepare/review regulatory documents (IND, IMPD, BLA, MAA)
• manage regulatory systems
• develop long-term CMC strategies
• support FDA and international inspections
• ensure compliance with 21 CFR Part 1271 and global regulations
• collaborate with Quality, Manufacturing, and R&D teams.

Requirements

• minimum 5 years in biotech/pharmaceutical industry, with 1-2 years in Regulatory Affairs preferred
• proven experience in CMC submissions for biologics, cell therapies, and device combinations
• strong knowledge of ICH GxP, product lifecycle management, and international regulatory standards

HighValue

• biologics and cell therapy focus
• late-stage clinical or commercial development
• FDA RMAT and Fast Track designations
• expertise in aseptic processing, human tissue regulations, and international submissions (especially Europe)

WorkSetup

• Fully remote in Durham, NC area
• no travel specified