Global CMC Regulatory Lead, Small Molecules (Remote)

Scorpion Therapeutics; United States; Remote; USD 135,000 - 195,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director, Regulatory Affairs - CMC to drive global regulatory strategy for small molecule drug programs. You will oversee CMC documentation, lifecycle management, and post-approval changes while coordinating with Regulatory Affairs, Technical Operations, and Quality teams.

You will manage agency interactions and ensure adherence to GMP and ICH standards across regions, with travel up to 20% as needed for global filings and inspections.

Qualifications

• Bachelor's in a scientific discipline with 7-8+ years in Regulatory Affairs or CMC writing.
• Deep knowledge of small molecule development, GMP, ICH regulations, and global processes.
• Proven submissions experience and lifecycle change management.
• Strong collaboration, communication, and project management.

Responsibilities

• Oversee preparation of CMC documentation for filings (NDAs, INDs, MAAs).
• Lead lifecycle management and post-approval change strategies.
• Collaborate cross-functionally with Regulatory Affairs, Technical Operations, and Quality teams.
• Manage agency interactions and ensure regulatory compliance.

Skills

Regulatory strategy

CMC knowledge

Global regulatory processes

Project management

Cross-functional collaboration

Education

Bachelor's in a scientific discipline

Advanced degree (Masters/PhD)

Job description

Scorpion Therapeutics is seeking an Associate Director, Regulatory Affairs - CMC to drive global regulatory strategy for small molecule drug programs. You will oversee CMC documentation, lifecycle management, and post-approval changes while coordinating with Regulatory Affairs, Technical Operations, and Quality teams.

You will manage agency interactions and ensure adherence to GMP and ICH standards across regions, with travel up to 20% as needed for global filings and inspections.