Associate Director, Regulatory CMC

Scorpion Therapeutics; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks an accomplished Regulatory CMC lead to develop and execute global CMC strategies for vaccine products, overseeing preparation, review, and submission of CMC documentation for investigational and post-approval filings. You will interact with health authorities, guide cross-functional teams, and ensure regulatory compliance with EMA, FDA, ICH, and other global regulations.

Remote work from the US with California-based salary range is offered.

Qualifications

• Bachelor's degree in a scientific discipline.
• 10+ years in vaccine/biotech with CMC experience (BLA/IND/IMPD submissions).
• Proficiency with LIMS, SAP, TrackWise, Veeva.
• Strong strategic, communication, and project management skills.
• Advanced knowledge of regulatory guidelines.

Responsibilities

• Develops global regulatory CMC strategies for vaccine products.
• Leads preparation, review, and submission of CMC documentation for regulatory filings.
• Interacts with health authorities and provides regulatory guidance to cross-functional teams.
• Leads CMC-related meetings with regulators and monitors evolving regulatory requirements.

Skills

Regulatory strategy

Cross-functional leadership

Project management

Communications

Education

Bachelor's degree in a scientific discipline

Tools

LIMS

SAP

TrackWise

Veeva

Job description

Role

Develops and executes global regulatory CMC strategies for multiple vaccine products, leading preparation, review, and submission of CMC documentation for investigational and post-approval filings.

Responsibilities

manages interactions with health authorities, provides regulatory guidance to cross-functional teams, and ensures compliance with EMA, FDA, ICH, and other global regulations. Leads CMC-related meetings with regulators, assesses product compliance, and monitors evolving regulatory requirements.

Qualifications

Bachelor's in a scientific discipline; minimum 10 years in vaccine or biotech industries, with experience in CMC sections of BLA, IND, or IMPD submissions; proficiency with LIMS, SAP, TrackWise, Veeva; strong strategic, communication, and project management skills; advanced knowledge of regulatory guidelines.

High-Value

vaccine development, biologics, biologic manufacturing, BLA and post-approval submissions, global regulatory compliance, CMC strategy, remote work with California-based salary range.

Collaboration

reports to the Executive Director, CMC Regulatory; works across development, manufacturing, quality, and regulatory teams.

Location

San Carlos, CA or US remote; work arrangement is remote.