Biologics CMC Regulatory Lead — Global Strategy & Lifecycle

Scorpion Therapeutics; United States; On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Employer 401(k) match

Generous PTO

Job summary

Scorpion Therapeutics is seeking an experienced Regulatory Affairs leader to drive global CMC regulatory strategies for biologics across development and commercial programs, including late-stage and rare disease therapies.

You will partner with cross-functional teams to align CMC plans with global requirements, manage Health Authority interactions, and contribute to lifecycle management from INDs to post-approval changes.

Qualifications

• BS in a scientific discipline is required; MS/PhD preferred.
• 8+ years Regulatory Affairs in biotech/pharma with significant CMC experience.
• Knowledge of FDA/EMA/MHRA/PMDA/Health Canada/ICH and global CMC requirements.

Responsibilities

• Develop and execute global CMC regulatory strategies.
• Lead CMC regulatory workstreams; assess risks and mitigation strategies.
• Prepare/review/submit CMC content for INDs, IMPDs/CTAs, BLAs/NDAs, MAAs, amendments, supplements, variations, and annual reports.
• Author/review Module 2 and Module 3 content.
• Lead Health Authority interactions; support registration milestones and inspection readiness.
• Develop post-approval CMC change and lifecycle management strategies (manufacturing/analytical changes, site transfers, validation, comparability).
• Provide technical regulatory guidance for biologics (mAbs, recombinant/fusion proteins, complex modalities).
• Advise on cell line/process development, scale-up/validation, commercial manufacturing, formulation/fill-finish, and tech transfers; oversee analytical characterization/control strategies (CQAs, CPPs, specs, product characterization).

Skills

Regulatory leadership

CMC regulatory

Biologics knowledge

Global submissions

Project management

Cross-functional collaboration

Education

BS in scientific discipline

MS/PhD preferred

Job description

Scorpion Therapeutics is seeking an experienced Regulatory Affairs leader to drive global CMC regulatory strategies for biologics across development and commercial programs, including late-stage and rare disease therapies.

You will partner with cross-functional teams to align CMC plans with global requirements, manage Health Authority interactions, and contribute to lifecycle management from INDs to post-approval changes.