Lead, CMC Dossier & Regulatory Strategy (AI-Driven)

Scorpion Therapeutics; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health benefits

Parental leave (14 weeks)

Job summary

Scorpion Therapeutics in Massachusetts seeks a senior CMC regulatory leader to guide dossier preparation and development, aligning strategies across CMC activities to accelerate pathways to clinic and patients.

You will lead the Dossier Subgroup/Submission Taskforce, ensure on-time delivery for regulatory submissions, and drive digital transformation and AI/ML applications within CMC documentation, collaborating with internal and external partners.

Qualifications

• PhD, MS, or equivalent in pharmaceutical drug development.
• Deep knowledge of pharmaceutical development is mandatory.
• Minimum 5 years’ experience in CMC development.
• Proven track record authoring CMC dossiers.
• Understanding regulatory documents for milestones and inquiries.
• Ability to embrace digital transformation and AI/ML applications.

Responsibilities

• Lead CMC dossier prep and development processes.
• Align dossier strategy with CMC activities to support expedited pathways.
• Lead CMC sub-team for authoring, review, comment resolution, and approval of CMC dossiers.
• Ensure timely delivery of CMC dossiers for regulatory submissions (IND/IMPD/CTN/IB/BP; BLA/NDA/MAA/JNDA).
• Ensure consistency across CMC dossiers and other modules (clinical and preclinical).
• Contribute to improving submission templates and authoring guides with CMC and Digital teams.
• Support M&A/licensing due diligence by assessing CMC dossier content.
• Drive AI-powered solutions and digital tools to transform preparation of CMC regulatory documents.

Skills

CMC development

Dossier authoring

Regulatory strategy

Digital transformation

AI/ML applications

Leadership

Cross-functional collaboration

Regulatory submissions

Education

PhD or MS in pharmaceutical sciences

Tools

Vault RIM

Word

Adobe

Job description

Scorpion Therapeutics in Massachusetts seeks a senior CMC regulatory leader to guide dossier preparation and development, aligning strategies across CMC activities to accelerate pathways to clinic and patients.

You will lead the Dossier Subgroup/Submission Taskforce, ensure on-time delivery for regulatory submissions, and drive digital transformation and AI/ML applications within CMC documentation, collaborating with internal and external partners.